INERTIA CONNEXX Modular Pedicle Screw System
FDA 510(k) K221905 · Nexxt Spine, LLC
510(k) numberK221905
Submission
- Device name
- INERTIA CONNEXX Modular Pedicle Screw System
- Applicant
- Nexxt Spine, LLC
Noblesville, IN, US - Received
- June 30, 2022
- Decision date
- July 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Other 510(k)s with product code NKB
| 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 |
More from L&K BIOMED Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243838 | NEXXT MATRIXX® SI SystemOUR · Traditional | 03/14/2025SE |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate SystemKWQ · Special | 03/22/2024SE |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/20/2023SE |
| K220291 | NEXXT SPINE NAVIGATION SystemOLO · Traditional | 03/31/2022SE |
| K202230 | NEXXT MATRIXX Stand Alone ALIF SystemOVD · Traditional | 12/15/2020SE |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQ · Traditional | 09/17/2020SE |
| K200969 | NEXXT MATRIXX SystemMAX · Special | 05/21/2020SE |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemOVE · Special | 03/23/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | 02/24/2020SE |
| K193370 | Nexxt Matrixx SystemMAX · Special | 01/21/2020SE |
Questions and answers
When was INERTIA CONNEXX Modular Pedicle Screw System cleared by the FDA?
INERTIA CONNEXX Modular Pedicle Screw System (K221905) received a 510(k) decision of Substantially Equivalent on July 28, 2022, 28 days after the submission was received.
What is the product code of K221905?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.