Thoracolumbosacral Pedicle Screw System
FDA product code NKB · Class II (moderate risk) · 21 CFR 888.3070 · Orthopedic
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
906510(k) clearances
0PMA approvals
180recalls
Implantimplanted device
Manufacturers
- Medtronic Sofamor Danek 50
- Medtronic Sofamor Danek USA, Inc. 48
- Depuy Spine, Inc. 30
- Globus Medical, Inc. 24
- Life Spine, Inc. 22
- Stryker Spine 22
- Alphatec Spine, Inc. 20
- K2m, Inc. 20
- L&K BIOMED Co., Ltd. 17
- Medos International SARL 15
- SeaSpine Orthopedics Corporation 14
- Zimmer Spine, Inc. 13
- Pioneer Surgical Technology 13
- Spineology, Inc. 12
- CarboFix Orthopedics , Ltd. 12
- Spinal Elements, Inc. 11
- Synthes Spine 10
- Nu Vasive, Incorporated 10
- Stryker Corporation 10
- Ebi, L.P. 10
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | Spineart SA | 05/01/2026SE |
| K252542 | LEO Spinal SystemNKB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/29/2026SE |
| K253940 | M.U.S.T. Pedicle Screw System - ExtensionNKB · Traditional | Medacta International S.A. | 04/28/2026SE |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemNKB · Traditional | Medtronic Sofamor Danek USA, Inc. | 04/21/2026SE |
| K254274 | ARx® SAI Implant SystemNKB · Traditional | Life Spine, Inc. | 04/16/2026SE |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 04/03/2026SE |
| K254247 | Osteomni Spinal Fixation SystemNKB · Traditional | Osteomni, Inc. | 02/24/2026SE |
| K253169 | Duet Spinal Fixation SystemNKB · Traditional | Box Spine, LLC | 02/23/2026SE |
| K253545 | Vulcan Spinal SystemNKB · Traditional | K2m, Inc. | 02/10/2026SE |
| K252461 | Swedge Pedicle Screw Fixation System Bezier RodNKB · Traditional | Spinal Resources, Inc. | 01/13/2026SE |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 01/07/2026SE |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)NKB · Special | Medtronic Sofamor Danek USA, Inc. | 01/07/2026SE |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 12/17/2025SE |
| K253093 | Vital Spinal Fixation SystemNKB · Traditional | Highridge Medical, LLC | 12/17/2025SE |
| K252729 | Universal Spinal SystemNKB · Traditional | Double Medical Technology, Inc. | 11/18/2025SE |
| K253335 | CD Horizon Spinal SystemNKB · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K252730 | Fule Spinal Fixation SystemNKB · Traditional | Beijing Fule Science & Technology Development… | 10/24/2025SE |
| K253249 | TriALTIS Spine SystemNKB · Special | Medos International SARL | 10/21/2025SE |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemNKB · Traditional | Astura Medical | 10/21/2025SE |
| K242827 | A8 INTEGR8 Porous Pedicle ScrewsNKB · Traditional | Allumin8, Inc. | 10/20/2025SE |
| K253331 | PressON Spinal Fixation SystemNKB · Special | Nexus Spine | 10/14/2025SE |
| K252437 | JAZZ Spinal SystemNKB · Special | Implanet | 08/28/2025SE |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/08/2025SE |
| K251719 | Momentum® Posterior Spinal Fixation SystemNKB · Special | Ulrich Medical USA, Inc. | 07/01/2025SE |
| K250908 | Virata Spinal Fixation SystemNKB · Traditional | SeaSpine Orthopedics Corporation | 06/18/2025SE |
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsNKB · Traditional | Ht Medical D.B.A. Xenix Medical | 06/12/2025SE |
| K251131 | Annex® 2 Adjacent Level SystemNKB · Traditional | Spine Wave, Inc. | 06/06/2025SE |
| K250582 | COLONNADE Posterior Screw Fixation SystemNKB · Traditional | CG Bio Co., Ltd. | 05/08/2025SE |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw SystemNKB · Traditional | Eminent Spine | 04/28/2025SE |
| K250092 | HC Biologics Osteopoint Spinal Fixation SystemNKB · Traditional | HC Biologics, LLC | 03/27/2025SE |
| K242900 | VADER® Pedicle System and VADER®one Pedicle SystemNKB · Traditional | Icotec AG | 02/27/2025SE |
| K243916 | Primus Spinal Fixation SystemNKB · Traditional | Spinal Elements, Inc. | 02/21/2025SE |
| K243908 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 02/03/2025SE |
| K243249 | TriALTIS Spine SystemNKB · Traditional | Medos International SARL | 01/17/2025SE |
| K243946 | EffortMed Spinal Fixation SystemNKB · Traditional | Effortmed, LLC | 01/15/2025SE |
| K243259 | MASADA Modular Spinal Fixation SystemNKB · Traditional | Astura Medical | 01/07/2025SE |
| K243693 | NEO Pedicle Screw SystemNKB · Special | Neo Medical SA | 12/23/2024SE |
| K242297 | Reform Pedicle Screw SystemNKB · Traditional | Precision Spine, Inc. | 12/17/2024SE |
| K243281 | LOCK-IN Spinal Fixation SystemNKB · Traditional | Lock-In USA Corp | 12/13/2024SE |
| K231655 | 4CIS® Chiron Spinal Fixation SystemNKB · Special | Solco Biomedical Co., Ltd. | 11/26/2024SE |
| K242764 | MediRod Pedicle Screw SystemNKB · Traditional | Cmf Medicon Surgical, Inc. | 11/13/2024SE |
| K243004 | Xpine Spinal Fixation SystemNKB · Traditional | Jeil Medical Corporation | 11/08/2024SE |
| K243106 | CarboClear® Hybrid Pedicle Screw SystemNKB · Traditional | CarboFix Orthopedics , Ltd. | 11/05/2024SE |
| K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemNKB · Traditional | Spinal Alignment Solutions, Inc. | 10/28/2024SE |
| K243007 | CD Horizon Spinal SystemNKB · Special | Medtronic Sofamor Danek USA, Inc. | 10/23/2024SE |
| K242899 | NOVA Minimally Invasive SystemNKB · Special | Baui Biotech Co., Ltd. | 10/17/2024SE |
| K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemNKB · Traditional | Greens Surgicals Pvt. , Ltd. | 10/10/2024SE |
| K241657 | MSFX Mikron Spinal Fixation SystemNKB · Traditional | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 09/30/2024SE |
| K242042 | TriALTIS Spine SystemNKB · Traditional | Medos International SARL | 09/09/2024SE |
| K240233 | Pitkar Spinal Pedicle Screw SystemNKB · Traditional | S.H.Pitkar Orthotools Pvt. , Ltd. | 09/09/2024SE |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special | Eminent Spine | 09/03/2024SE |
| K240180 | Orthopeasia Spinal Fixation SystemNKB · Traditional | Orthopeasia Co., Ltd. | 08/30/2024SE |
| K241892 | Cortera Spinal Fixation SystemNKB · Traditional | Xtant Medical Holdings, Inc. | 08/02/2024SE |
| K233793 | CarboClear® X Pedicle Screw SystemNKB · Traditional | CarboFix Orthopedics , Ltd. | 08/01/2024SE |
| K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation SystemNKB · Traditional | Pantheon Spinal | 07/26/2024SE |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special | Clariance | 07/24/2024SE |
| K241519 | Invictus® Small Stature Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 06/21/2024SE |
| K240963 | Spinal SystemNKB · Traditional | Teslake, Inc. | 06/06/2024SE |
| K241258 | Ingenix Spinal SystemNKB · Special | Ingenium Spine | 06/04/2024SE |
| K241276 | Vector Pedicle Screw SystemNKB · Traditional | Innovasis, Inc. | 05/20/2024SE |
| K240685 | Salvo® Spine SystemNKB · Traditional | Spine Wave, Inc. | 05/06/2024SE |
| K240392 | JAZZ Spinal SystemNKB · Traditional | Implanet | 05/06/2024SE |
| K240526 | POWEReam Xia/SerratoNKB · Traditional | Stryker Instruments | 04/29/2024SE |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKB · Special | Clariance | 04/26/2024SE |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…NKB · Special | CarboFix Orthopedics , Ltd. | 04/25/2024SE |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…NKB · Traditional | SeaSpine Orthopedics Corporation | 04/19/2024SE |
| K240737 | G Surgical Marksman MIS SystemNKB · Special | G Surgical, LLC | 04/05/2024SE |
| K240350 | AnyPlus II Spinal Fixation SystemNKB · Traditional | GS Medical Co., Ltd. | 04/03/2024SE |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)NKB · Traditional | Medtronic Sofamor Danek USA, Inc. | 03/27/2024SE |
| K240539 | Vital Spinal Fixation SystemNKB · Special | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 03/15/2024SE |
| K232607 | 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…NKB · Traditional | Solco Biomedical Copany India Private Limited | 02/27/2024SE |
| K232628 | VADER® Pedicle SystemNKB · Traditional | Icotec AG | 02/26/2024SE |
| K234048 | M.U.S.T. Pedicle Screw System - ExtensionNKB · Traditional | Medacta International S.A. | 02/13/2024SE |
| K233960 | INNOVERSE Spinal SystemNKB · Traditional | Innosys Co., Ltd. | 02/06/2024SE |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsNKB · Special | CarboFix Orthopedics , Ltd. | 01/10/2024SE |
| K233300 | POWEReam 1/4 DriveNKB · Traditional | Stryker Instruments | 12/26/2023SE |
| K233684 | TriALTIS Spine SystemNKB · Special | Medos International SARL | 12/12/2023SE |
| K233455 | ARx MIS Spinal Screw SystemNKB · Traditional | Life Spine, Inc. | 12/12/2023SE |
| K232719 | ProMIS Extension Rod SystemNKB · Traditional | Premia Spine, Ltd. | 11/21/2023SE |
| K231443 | Mini-OSTEO Pedicle Fixation SystemNKB · Traditional | Osteomed Indústria E Comércio DE Implantes Ltda | 11/21/2023SE |
| K231694 | MASADA Modular Spinal Fixation SystemNKB · Traditional | Astura Medical | 11/16/2023SE |
| K233234 | PressON Spinal Fixation SystemNKB · Special | Nexus Spine, LLC | 10/26/2023SE |
| K231737 | ANAX 5.5 Spinal SystemNKB · Special | Innosys Co., Ltd. | 10/26/2023SE |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | Spineart SA | 10/25/2023SE |
| K232586 | Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal SystemNKB · Traditional | K&J Consulting Corp. | 10/24/2023SE |
| K232561 | Ripley Spinal Screw System by SAGICONKB · Traditional | Sagico VA USA, LLC | 10/23/2023SE |
| K231744 | VyLink Spinal Screw SystemNKB · Traditional | Vy Spine, LLC | 10/13/2023SE |
| K230116 | Vital Spinal Fixation SystemNKB · Traditional | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 10/11/2023SE |
| K232341 | CarboClear® Pedicle Screw SystemNKB · Traditional | CarboFix Orthopedics , Ltd. | 10/10/2023SE |
| K231658 | VEOS Spinal Fixation SystemNKB · Traditional | Spineway | 10/10/2023SE |
| K230961 | Zeus Spinal SystemNKB · Special | Shanghai Sanyou Medical Co, Ltd. | 10/10/2023SE |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/29/2023SE |
| K232275 | Invictus® Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 09/27/2023SE |
| K231479 | TriALTIS Spine SystemNKB · Traditional | Medos International SARL | 09/22/2023SE |
| K230974 | NIDO Pedicle Screw SystemNKB · Traditional | Kalitec Medical | 09/15/2023SE |
| K232218 | Zenius Spinal SystemNKB · Special | Medyssey USA, Inc. | 08/24/2023SE |
| K231811 | Zavation Connector SystemNKB · Traditional | Zavation Medical Products, LLC | 08/22/2023SE |
| K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…NKB · Special | Medtronic Sofamor Danek USA, Inc. | 08/16/2023SE |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…NKB · Special | L&K BIOMED Co., Ltd. | 08/14/2023SE |
| K231098 | LineSider® Spinal SystemNKB · Traditional | Integrity Implants, Inc. | 08/07/2023SE |
| K231931 | Adena-Zina Spinal SystemNKB · Special | Shanghai Sanyou Medical Co, Ltd. | 07/28/2023SE |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw SystemNKB · Special | Nexxt Spine, LLC | 07/20/2023SE |
| K231844 | ProMIS Fixation SystemNKB · Special | Premia Spine, Ltd. | 07/07/2023SE |
| K223806 | VERTICALE® Triangular Fixation SystemNKB · Traditional | Silony Medical GmbH | 07/06/2023SE |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…NKB · Traditional | CarboFix Orthopedics , Ltd. | 07/03/2023SE |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…NKB · Special | L&K BIOMED Co., Ltd. | 06/27/2023SE |
| K230762 | EDEN Spinal Fixation MIS SystemNKB · Special | Jmt Co., Ltd. | 06/15/2023SE |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…NKB · Traditional | Stryker Spine | 06/08/2023SE |
| K223096 | Dark Star Deformity Pedicle Screw SystemNKB · Traditional | Republic Spine, LLC | 05/26/2023SE |
| K222229 | Advanced LumFix Spinal Fixation SystemNKB · Traditional | CG Bio Co., Ltd. | 05/25/2023SE |
| K223529 | PressON Spinal Fixation SystemNKB · Traditional | Nexus Spine, LLC | 05/02/2023SE |
| K212220 | ArtFX Spinal Fixation SystemNKB · Traditional | Artfx Medical, LLC | 04/20/2023SE |
| K230766 | Altus Spine Monaco Pedicle Screw SystemNKB · Special | Altus Spine | 04/19/2023SE |
| K230482 | Swedge Pedicle Screw Fixation SystemNKB · Special | Spinal Resources, Inc. | 03/23/2023SE |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw SystemNKB · Special | OrthoPediatrics Corp. | 03/23/2023SE |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…NKB · Special | L&K BIOMED Co., Ltd. | 02/28/2023SE |
| K230063 | G Surgical Marksman Spinal Deformity SystemNKB · Special | G Surgical, LLC | 02/09/2023SE |
| K223494 | CD Horizon Spinal SystemNKB · Traditional | Medtronic | 01/23/2023SE |
| K223181 | NuVasive Reline SystemNKB · Traditional | Nu Vasive, Incorporated | 01/11/2023SE |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…NKB · Special | L&K BIOMED Co., Ltd. | 12/23/2022SE |
| K223273 | ASTRA Spine SystemNKB · Traditional | Spinecraft, LLC | 12/22/2022SE |
| K222614 | Zavation Spinal SystemNKB · Traditional | Zavation Medical Products, LLC | 12/05/2022SE |
| K222516 | Mercury® II Spinal SystemNKB · Traditional | Spinal Elements, Inc. | 12/01/2022SE |
| K223274 | Momentum® MIS Posterior Spinal Fixation SystemNKB · Special | Ulrich Medical USA | 11/28/2022SE |
| K212700 | Dyflex-IINKB · Traditional | Taeyeon Medical Co., Ltd. | 11/15/2022SE |
| K222031 | Spinal Inner Fixation SystemNKB · Traditional | Changzhou Geasure Medical Apparatus and… | 10/28/2022SE |
| K222415 | Rexious Spinal Fixation SystemNKB · Traditional | Dio Medical Corporation | 10/25/2022SE |
| K222473 | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra RodsNKB · Traditional | Medos-International Sarl | 10/13/2022SE |
| K221646 | CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON…NKB · Traditional | Medtronic Sofamor Danek USA, Inc. | 10/04/2022SE |
| K220297 | True Tulip, True M.I.S.NKB · Traditional | Innovative Surgical Designs, Inc. | 09/16/2022SE |
| K211027 | Altus Spine Pedicle Screw SystemNKB · Traditional | Altus Partners, LLC | 09/16/2022SE |
| K222110 | Mariner RDX SystemNKB · Traditional | SeaSpine Orthopedics Corporation | 09/07/2022SE |
| K221745 | Sterile Posterior Spinal Fixation SystemNKB · Special | Shanghai Reach Medical Instrument Co, Ltd. | 08/31/2022SE |
| K222362 | Salvo® Spine SystemNKB · Special | Spine Wave, Inc. | 08/29/2022SE |
| K221403 | Cortera Spinal Fixation SystemNKB · Traditional | Surgalign Spine Technologies | 08/19/2022SE |
| K221776 | NextGen Pedicle Screw SystemNKB · Traditional | Corelink, LLC | 08/09/2022SE |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw SystemNKB · Special | Nexxt Spine, LLC | 07/28/2022SE |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener SystemNKB · Traditional | OsteoCentric Technologies | 07/28/2022SE |
| K220486 | Kentrospine PSS Pedicle Screw SystemNKB · Traditional | Rivarp Medical Private Limited | 07/22/2022SE |
| K201788 | EDEN Spinal Fixation SystemNKB · Traditional | Jmt Co., Ltd. | 06/23/2022SE |
| K211981 | KHEIRON® Spinal Fixation SystemNKB · Traditional | S.M.A.I.O | 06/09/2022SE |
| K203233 | 4CIS Chiron Spinal Fixation SystemNKB · Special | Solco Biomedical Co., Ltd. | 06/01/2022SE |
| K221244 | CD Horizon Spinal SystemNKB · Special | Medtronic | 05/25/2022SE |
| K220285 | PINE Pedicle Screw SystemNKB · Traditional | Tdm Co., Ltd. | 05/19/2022SE |
| K220341 | ARx Modular Spinal SystemNKB · Traditional | Life Spine, Inc. | 05/02/2022SE |
| K220724 | CD Horizon Spinal System and PASS LP Spinal SystemNKB · Special | Medicrea International | 04/08/2022SE |
| K214006 | Invictus® Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 04/04/2022SE |
| K220025 | ARx® Spinal SystemNKB · Traditional | Life Spine, Inc. | 03/31/2022SE |
| K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)NKB · Special | Medos International SARL | 03/08/2022SE |
| K213750 | VyLink Spinal Screw SystemNKB · Traditional | Vy Spine, LLC | 02/28/2022SE |
| K212627 | True Tulip, True M.I.S.NKB · Special | Innovative Surgical Designs, Inc. | 02/18/2022SE |
| K213470 | PERLA® TL Posterior Osteosynthesis SystemNKB · Traditional | Spineart | 01/21/2022SE |
| K213281 | PASS LP Spinal System, CD Horizon Spinal SystemNKB · Traditional | Medicrea International SA | 01/05/2022SE |
| K213460 | Invictus Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 12/10/2021SE |
| K212692 | Mariner Pedicle Screw SystemNKB · Special | SeaSpine Orthopedics Corporation | 09/21/2021SE |
| K203607 | MOSS VRS Spinal SystemNKB · Traditional | Biedermann Motech GmbH & Co. KG | 08/20/2021SE |
| K212185 | Golden Isles Pedicle Screw SystemNKB · Traditional | Intelivation, LLC | 08/19/2021SE |
| K212066 | Adena-Zina SystemNKB · Traditional | Shanghai Sanyou Medical Co, Ltd. | 08/16/2021SE |
| K211414 | KHEIRON Spinal Fixation SystemNKB · Traditional | S.M.A.I.O | 08/10/2021SE |
| K211958 | CD Horizon Spinal SystemNKB · Special | Medtronic Sofamor Danek USA, Inc. | 07/21/2021SE |
| K210963 | ENNOVATE Spinal SystemNKB · Traditional | Aesculap Implant Systems, LLC | 07/19/2021SE |
| K203023 | Pisces Spinal SystemNKB · Traditional | Ortho Development Corporation | 07/14/2021SE |
| K211113 | Zavation Spinal SystemNKB · Traditional | Zavation Medical Products, LLC | 07/12/2021SE |
| K211606 | Mariner Deformity SystemNKB · Special | SeaSpine Orthopedics Corporation | 06/23/2021SE |
| K201737 | Posterior Spinal Fixation SystemNKB · Traditional | Shanghai Reach Medical Instrument Co, Ltd. | 06/21/2021SE |
| K211323 | ASTRA Spine SystemNKB · Special | Spinecraft, LLC | 06/03/2021SE |
| K210306 | GII Spinal Fixation SystemNKB · Special | Coligne AG | 05/19/2021SE |
| K210816 | True Tulip, True M.I.S.NKB · Special | Innovative Surgical Designs, Inc. | 05/18/2021SE |
| K210874 | Reliance Spinal Screw SystemNKB · Special | Reliance Medical Systems, LLC | 05/13/2021SE |
| K210637 | CD Horizon Spinal SystemNKB · Traditional | Medtronic | 04/30/2021SE |
| K210549 | ARx Spinal SystemNKB · Traditional | Life Spine, Inc. | 04/22/2021SE |
| K210427 | M.U.S.T. Midline Cortical (MC) Screw SystemNKB · Traditional | Medacta International S.A. | 04/20/2021SE |
| K210420 | Goblin and Goblin LS Pedicle Screw SystemsNKB · Traditional | Medynus, Inc. | 04/19/2021SE |
| K210539 | CoreLink Midline Fixation SystemNKB · Traditional | Corelink, LLC | 04/15/2021SE |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsNKB · Special | CarboFix Orthopedics , Ltd. | 04/06/2021SE |
| K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemNKB · Traditional | Auxein Medical Private Limited/71164 | 04/06/2021SE |
| K210275 | Polaris Spinal SystemNKB · Special | Zimmer Biomet Spine, Inc. | 04/02/2021SE |
| K201420 | Republic Spine Dark Star Spinal SystemNKB · Traditional | Republic Spine, LLC | 03/05/2021SE |
| K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine SystemNKB · Traditional | Solco Biomedical Company India Private Limited | 02/18/2021SE |
| K203507 | Vitality® Spinal Fixation SystemNKB · Traditional | Zimmer Biomet Spine, Inc. | 01/28/2021SE |
| K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsNKB · Traditional | Medacta International S.A. | 01/26/2021SE |
| K200922 | Altus Spine HA Pedicle Screw SystemNKB · Special | Altus Partners, LLC | 01/26/2021SE |
| K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPSNKB · Traditional | Globus Medical, Inc. | 01/19/2021SE |
| K203506 | PERLA® TL posterior osteosynthesis systemNKB · Traditional | Spineart | 01/15/2021SE |
| K202505 | GetSet Surgical GoPLF! Posterior Lateral Fusion SystemNKB · Traditional | Getset Surgical, SA | 01/11/2021SE |
| K203452 | Nano FortiFix® SystemNKB · Special | Nanovis, LLC | 12/22/2020SE |
| K203222 | PERLA TL Posterior Osteosynthesis SystemNKB · Traditional | Spineart | 12/17/2020SE |
| K203163 | ARx Illiac Spinal Screw SystemNKB · Traditional | Life Spine, Inc. | 12/17/2020SE |
| K200789 | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemNKB · Special | L&K BIOMED Co., Ltd. | 12/04/2020SE |
| K203367 | LineSider Spinal SystemNKB · Special | Integrity Implants, Inc. | 12/03/2020SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3226-2026 | SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm…The proximal thread depth of the spinal device is out of design specification. | Seaspine Orthopedics Corporation | 08/19/2026Open, Classified |
| Z-2762-2026 Class II | SeaSpine Polyaxial Head REF Number: 41-3010Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. | Seaspine Orthopedics Corporation | 05/28/2026Open, Classified |
| Z-2859-2026 Class II | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw SystemPedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to… | Innovasis, Inc | 05/22/2026Open, Classified |
| Z-0478-2026 Class II | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The…Polyaxial screws do not meet performance standards. | Orthofix U.S. LLC | 09/19/2025Open, Classified |
| Z-2280-2025 Class II | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW…Cannulated fenestrated polyaxial screws may be incorrectly labeled | Spineart SA | 06/30/2025Open, Classified |
| Z-2279-2025 Class II | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW…Cannulated fenestrated polyaxial screws may be incorrectly labeled | Spineart SA | 06/30/2025Open, Classified |
| Z-0752-2025 Class II | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25…Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. | Seaspine Orthopedics Corporation | 10/29/2024Open, Classified |
| Z-0751-2025 Class II | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature…Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. | Seaspine Orthopedics Corporation | 10/29/2024Open, Classified |
| Z-0125-2025 Class II | Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been… | XTANT Medical Holdings, Inc | 08/21/2024Open, Classified |
| Z-1758-2024 Class II | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S…Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head.… | Spineart SA | 03/15/2024Open, Classified |
| Z-1620-2024 Class II | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha…Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of… | Seaspine Orthopedics Corporation | 02/28/2024Open, Classified |
| Z-1605-2024 Class II | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF:…Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative… | Seaspine Orthopedics Corporation | 02/15/2024Open, Classified |
| Z-0846-2024 Class II | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5…Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw… | XTANT Medical Holdings, Inc | 11/28/2023Open, Classified |
| Z-0639-2024 Class II | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital…Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves… | Zimmer Biomet Spine Inc. | 10/16/2023Open, Classified |
| Z-0728-2023 Class II | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque… | Icotec Ag | 11/03/2022Open, Classified |
| Z-0421-2023 Class II | LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead…Potential for intraoperative screw head separation at weld location. | Integrity Implants Inc. | 08/03/2022Terminated |
| Z-1638-2022 Class II | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and…Potential for the incorrect screw to be included in the package. | Aesculap Implant Systems LLC | 07/15/2022Open, Classified |
| Z-1572-2022 Class II | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers…The type of screw printed on the traceability record for the patient label is incorrect, but the type of… | Safe Orthopaedics LLC | 06/03/2022Completed |
| Z-0420-2023 Class II | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.…Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which… | Integrity Implants Inc. | 01/27/2022Terminated |
| Z-0419-2023 Class II | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated.…Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which… | Integrity Implants Inc. | 01/27/2022Terminated |
| Z-0418-2023 Class II | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated.…Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which… | Integrity Implants Inc. | 01/27/2022Terminated |
| Z-1975-2021 Class II | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft…Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. | Spineart SA | 04/09/2021Terminated |
| Z-0570-2021 Class II | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral…Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the… | Zimmer Biomet, Inc. | 11/17/2020Terminated |
| Z-1448-2022 Class II | AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | Aesculap Implant Systems LLC | 09/08/2020Terminated |
| Z-1447-2022 Class II | AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | Aesculap Implant Systems LLC | 09/08/2020Terminated |
| Z-1446-2022 Class II | AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | Aesculap Implant Systems LLC | 09/08/2020Terminated |
| Z-1445-2022 Class II | AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | Aesculap Implant Systems LLC | 09/08/2020Terminated |
| Z-1444-2022 Class II | AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | Aesculap Implant Systems LLC | 09/08/2020Terminated |
| Z-1443-2022 Class II | AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | Aesculap Implant Systems LLC | 09/08/2020Terminated |
| Z-2742-2020 Class II | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System…Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised… | OrthoPediatrics Corp | 07/06/2020Open, Classified |
| Z-2672-2020 Class II | ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM6.0x50mm poly-reduction screws were laser etched 6.0x45 | U&I Corp. | 05/26/2020Terminated |
| Z-2234-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2232-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2231-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2230-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2229-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2228-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2227-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2226-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2225-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2224-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2223-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2222-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2221-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2220-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2219-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2218-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2217-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2216-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |
| Z-2215-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | Zimmer Biomet, Inc. | 05/05/2020Terminated |