Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
FDA product code KTT · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
404510(k) clearances
0PMA approvals
88recalls
Implantimplanted device
Manufacturers
- Ebi, L.P. 35
- Synthes (Usa) 32
- Howmedica Corp. 22
- Howmedica Osteonics Corp. 19
- Smith & Nephew, Inc. 16
- Orthofix Srl 11
- Stryker Corporation 11
- Wrightmedicaltechnologyinc 11
- Zimmer, Inc. 10
- Alliance Medical Corp. 9
- DePuy Orthopaedics, Inc. 7
- Paragon 28, Inc. 6
- Electro-Biology, Inc. 5
- Smith & Nephew Richards, Inc. 5
- Vilex, LLC 5
- O'Tec Corp. 4
- Vanguard Medical Concepts, Inc. 4
- Fixano SA 4
- Kirschner Medical Corp. 4
- Merete Medical GmbH 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
| K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT · Traditional | Amdt Holdings, Inc. | 08/08/2025SE |
| K251128 | Extremity Medical External Fixation SystemKTT · Special | Extremity Medical, LLC | 05/07/2025SE |
| K243798 | Orthex External Fixation SystemKTT · Traditional | OrthoPediatrics Corp. | 03/07/2025SE |
| K241563 | Extremity Medical External Fixation SystemKTT · Traditional | Extremity Medical, LLC | 02/21/2025SE |
| K242861 | TrueLok ElevateKTT · Traditional | Orthofix Srl | 12/03/2024SE |
| K242452 | Monkey Bars Pin to Bar External Fixation SystemKTT · Traditional | Paragon 28, Inc. | 11/01/2024SE |
| K241769 | Response Ortho Metaphyseal Hinge Fixator SystemKTT · Traditional | Response Ortho Solutions, LLC | 09/18/2024SE |
| K233025 | Revolution External Plating SystemKTT · Traditional | New Standard Device Dba Metalogix | 05/30/2024SE |
| K240049 | LINK(TM) External FixatorKTT · Traditional | Metric Medical Devices, Inc. | 05/29/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | Stryker GmbH | 12/21/2023SE |
| K221787 | Auxein's DHS/DCS Plate SystemKTT · Traditional | Auxein Medical Private Limited | 11/30/2023SE |
| K232897 | Arthrex Small External Fixation SystemKTT · Special | Arthrex, Inc. | 10/18/2023SE |
| K232838 | Monkey RingsTM External Fixation SystemKTT · Special | Paragon 28, Inc. | 10/12/2023SE |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemKTT · Special | DePuy Synthes | 07/26/2023SE |
| K231461 | Smart Correction System (HA Half Pins)KTT · Special | Wishbone Medical, Inc. | 06/16/2023SE |
| K223786 | Orthex External Fixation SystemKTT · Traditional | OrthoPediatrics Corp. | 02/10/2023SE |
| K213905 | ONX Large External Fixation SystemKTT · Traditional | Orthonovis, Inc. | 08/25/2022SE |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half PinsKTT · Special | Wishbone Medical, Inc. | 06/06/2022SE |
| K220809 | Drive Rail SystemKTT · Special | OrthoPediatrics Corp. | 04/08/2022SE |
| K212895 | Paragon 28 External Ring Fixation SystemKTT · Traditional | Paragon 28, Inc. | 11/08/2021SE |
| K212044 | TrueLok EvoKTT · Traditional | Orthofix Srl | 11/05/2021SE |
| K212552 | Correx SoftwareKTT · Traditional | Vilex, LLC | 10/12/2021SE |
| K210953 | SMART Taylor Spatial FrameKTT · Traditional | Smith & Nephew, Inc. | 07/29/2021SE |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME)KTT · Special | Synthes (USA) Products, LLC | 05/25/2021SE |
| K211112 | OIC External Fixation SystemKTT · Special | Orthopaedic Implant Company | 05/05/2021SE |
| K203568 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 02/01/2021SE |
| K202833 | Sequel External Fixation DeviceKTT · Traditional | Sequel Medical, Inc. | 01/19/2021SE |
| K202810 | AutoStrut G2KTT · Traditional | Orthospin, Ltd. | 01/06/2021SE |
| K200491 | Bfix Orthopedic External Fixator SystemsKTT · Traditional | Aike (Shanghai) Medical Instrument Co., Ltd. | 01/05/2021SE |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…KTT · Traditional | Smith & Nephew | 12/08/2020SE |
| K202762 | Circular Fixation with Balanced Cable TransportKTT · Traditional | Smith & Nephew, Inc. | 11/16/2020SE |
| K200728 | Pitkar DeftFix SystemKTT · Traditional | S.H.Pitkar Orthotools Pvt. , Ltd. | 10/06/2020SE |
| K200123 | Accessories for the SixFix® Hexapod FixatorKTT · Traditional | Arrowhead De, LLC | 09/22/2020SE |
| K193368 | Smart Correction SystemKTT · Traditional | Wishbone Medical, Inc. | 09/18/2020SE |
| K200343 | FusionFrame Ring Lock SystemKTT · Traditional | Glw Medical Innovation | 09/14/2020SE |
| K202143 | Dynex MicroKTT · Traditional | Vilex, LLC | 09/11/2020SE |
| K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation SystemKTT · Traditional | Vilex, LLC | 08/24/2020SE |
| K200518 | Pitkar External Fixation System - Rail MechanismKTT · Traditional | S.H.Pitkar Orthotools Pvt. , Ltd. | 07/29/2020SE |
| K192181 | PRECICE Plating SystemKTT · Traditional | Nuvasive Specialized Orthopedics, Inc. | 11/07/2019SE |
| K190486 | Pitkar External Fixation SystemKTT · Traditional | S.H.Pitkar Orthotools Pvt. , Ltd. | 10/16/2019SE |
| K191241 | AutoStrutKTT · Traditional | Orthospin | 08/14/2019SE |
| K181630 | Revolution External Plating SystemKTT · Traditional | New Standard Device Dba Metalogix | 05/29/2019SE |
| K190069 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT · Traditional | Arrowhead De, LLC | 05/14/2019SE |
| K183682 | OIC External Fixation SystemKTT · Traditional | Orthopaedic Implant Company | 04/08/2019SE |
| K181528 | Austin Miller Large External Fixation SystemKTT · Traditional | Austin Miller Trauma, LLC | 02/28/2019SE |
| K182968 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 01/25/2019SE |
| K182154 | Depuy Synthes Femoral Neck SystemKTT · Traditional | Synthes (USA) Products, LLC | 10/16/2018SE |
| K173883 | External Fixation SystemKTT · Traditional | Life Spine, Inc. | 09/07/2018SE |
| K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation DevicesKTT · Traditional | Surgical Instrument Service and Savings, Inc. | 07/27/2018SE |
| K180832 | SALVATION External Fixation SystemKTT · Special | Wrightmedicaltechnologyinc | 06/06/2018SE |
| K172872 | DePuy Synthes Femoral Neck SystemKTT · Traditional | DePuy Synthes | 03/05/2018SE |
| K172438 | ARBOR External Fixation SystemKTT · Traditional | Globus Medical, Inc. | 01/12/2018SE |
| K171911 | Medline ReNewal Reprocessed Synthes External Fixation SystemsKTT · Traditional | Surgical Instrument Service and Savings, Inc. | 11/09/2017SE |
| K170146 | Galaxy UNYCO SystemKTT · Traditional | Orthofix Srl | 10/12/2017SE |
| K171211 | OIC External Fixation SystemKTT · Traditional | Orthopaedic Implant Company | 09/27/2017SE |
| K170482 | Spider Frame External Fixation SystemKTT · Traditional | Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S | 09/27/2017SE |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) SystemKTT · Traditional | Pega Medical, Inc. | 09/08/2017SE |
| K163486 | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO…KTT · Traditional | Hnm Total Recon, LLC | 07/24/2017SE |
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0KTT · Special | Orthofix Srl | 05/10/2017SE |
| K163656 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 04/14/2017SE |
| K163323 | Dolphix® External Fixation System MR ConditionalKTT · Traditional | Citieffe S.R.L. | 03/20/2017SE |
| K162033 | SALVATION External Fixation SystemKTT · Traditional | Wright Medical | 03/06/2017SE |
| K162032 | Arrowhead Mini-Rail FixatorKTT · Traditional | Arrowhead De, LLC | 02/21/2017SE |
| K160972 | Gexfix External FixationKTT · Traditional | Gexfix International Corp. | 12/28/2016SE |
| K161753 | Hoffman LRF SystemKTT · Traditional | Stryker GmbH | 11/15/2016SE |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT · Traditional | Synthes USA, LLC | 11/10/2016SE |
| K160830 | Integra External Fixation SystemKTT · Special | Ascension Orthopedics | 07/06/2016SE |
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) SystemKTT · Traditional | Stryker GmbH | 04/11/2016SE |
| K151881 | X-Fix Line AdditionsKTT · Traditional | Vilex IN Tennessee, Inc. | 03/24/2016SE |
| K151580 | D.N.E. External Fixation SystemKTT · Special | Dne, LLC | 02/16/2016SE |
| K153635 | SALVATION(R) External Fixation SystemKTT · Special | Wrightmedicaltechnologyinc | 01/13/2016SE |
| K153415 | Reprocessed Stryker External Fixation DevicesKTT · Special | Stryker Sustainability Solutions | 01/13/2016SE |
| K153233 | Galaxy UNYCO SystemKTT · Traditional | Orthofix Srl | 01/06/2016SE |
| K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…KTT · Traditional | Zimmer, Inc. | 12/30/2015SE |
| K152755 | FastFrame External Fixation System-Ankle SpanningKTT · Traditional | Zimmer, Inc. | 12/21/2015SE |
| K152484 | FastFrame External Fixation System - Distal RadiusKTT · Traditional | Zimmer, Inc. | 12/04/2015SE |
| K150640 | RX-FIX Mini Rail External FixatorKTT · Traditional | Wrightmedicaltechnologyinc | 12/01/2015SE |
| K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…KTT · Traditional | Zimmer, Inc. | 11/02/2015SE |
| K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4KTT · Traditional | Orthofix Srl | 09/28/2015SE |
| K152158 | ARIX Ankle SystemKTT · Traditional | Jeil Medical Corporation | 09/28/2015SE |
| K152045 | SALVATION® External Fixation SystemKTT · Special | Wrightmedicaltechnologyinc | 08/21/2015SE |
| K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…KTT · Traditional | Zimmer, Inc. | 05/01/2015SE |
| K150579 | Cardinal Health External Fixation SystemKTT · Traditional | Cardinalhealth | 04/29/2015SE |
| K150004 | SALVATION External Fixation SystemKTT · Traditional | Wrightmedicaltechnologyinc | 03/04/2015SE |
| K143220 | SIDEKICK EZ FRAME External Fixation SystemKTT · Traditional | Wrightmedicaltechnologyinc | 01/08/2015SE |
| K143125 | Orthofix True Lok Hexapod System VI.3KTT · Special | Orthofix Srl | 12/10/2014SE |
| K141760 | Orthofix Galaxy WristKTT · Traditional | Orthofix Srl | 12/08/2014SE |
| K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia KitKTT · Traditional | Orthofix Srl | 12/05/2014SE |
| K142520 | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareKTT · Special | Smith & Nephew, Inc. | 11/20/2014SE |
| K140961 | Hoffmann LRF (Limb Reconstruction Frame) SystemKTT · Traditional | Stryker Trauma AG | 11/10/2014SE |
| K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…KTT · Traditional | Advanced Orthopaedic Solutions, Inc. | 10/29/2014SE |
| K140463 | Integra External Fixation SystemKTT · Traditional | Ascension Orthopedic | 10/10/2014SE |
| K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation SystemKTT · Traditional | Zimmer, Inc. | 09/18/2014SE |
| K141078 | Orthofix Tl-Hex True Lok Hexalobe System (Tl-Hex)KTT · Traditional | Orthofix Srl | 09/02/2014SE |
| K140675 | Emerge External Fixation SystemKTT · Traditional | Emerge Medical, Inc. | 06/10/2014SE |
| K140822 | Drive Rail SystemKTT · Traditional | Devise Ortho, Inc. | 05/29/2014SE |
| K140158 | S.E.A.L. Fracture Fusion TubeKTT · Traditional | Dne, LLC | 05/29/2014SE |
| K131413 | Xtrafix Small External Fixation SystemKTT · Traditional | Zimmer, Inc. | 01/28/2014SE |
| K132363 | Dolphix External Fixation SystemKTT · Traditional | Citieffe S.R.L. | 01/16/2014SE |
| K130907 | Hoffmann LRF (Limb Reconstruction Frame) SystemKTT · Traditional | Stryker Trauma AG | 06/10/2013SE |
| K122777 | NBX - Non Bridging External Fixator HandKTT · Traditional | Nutek Orthopaedics, Inc. | 05/15/2013SE |
| K130479 | Ilizarov Drill Tip WiresKTT · Traditional | Smith & Nephew, Inc. | 05/14/2013SE |
| K130334 | Hoffmann LRF (Limb Reconstruction Frame System)KTT · Traditional | Stryker Trauma AG | 05/03/2013SE |
| K122210 | Newfix External Fixation SystemKTT · Traditional | Tecnologia Y Diseno Industrial, S.A DE C.V | 04/19/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | Synthes | 04/11/2013SE |
| K130044 | Sidekick Ez Frame External Fixation SystemKTT · Traditional | Wrightmedicaltechnologyinc | 04/05/2013SE |
| K122284 | Hoffmann 3KTT · Traditional | Stryker Corp. | 10/24/2012SE |
| K113770 | Orthofix Galaxy Fixation SystemKTT · Traditional | Orthofix Srl | 09/04/2012SE |
| K121252 | Hoffmann 3 Modular External Fixation SystemKTT · Traditional | Stryker Corp. | 07/25/2012SE |
| K113383 | Xtrafix External Fixation SystemKTT · Traditional | Extraortho, Inc. | 06/26/2012SE |
| K113384 | External Fixator St.A R 90 F4KTT · Traditional | Citieffe | 05/01/2012SE |
| K113327 | Hoffmann LRF (Limb Reconstruction Frame) SystemKTT · Traditional | Stryker Corp. | 03/29/2012SE |
| K111786 | Hoffmann 3 Modular External Fixation SystemKTT · Traditional | Stryker Corp. | 01/26/2012SE |
| K113123 | Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) SystemKTT · Traditional | The Orthopaedic Implant Company | 01/12/2012SE |
| K113106 | Dne External Fixation SystemKTT · Traditional | Dne, LLC | 01/04/2012SE |
| K112218 | Ace-Fischer(R), Tempfix(R), Hoffman Classic(Tm) External FixatorsKTT · Traditional | DePuy Orthopaedics, Inc. | 12/15/2011SE |
| K110426 | Dyna-Extor IIKTT · Traditional | Bk Meditech, Co., Ltd. | 11/02/2011SE |
| K111993 | FramewalkerKTT · Traditional | Quantum Medical Concepts, LLC | 10/24/2011SE |
| K111155 | Xtrafix External Fixation SystemKTT · Traditional | Extraortho, Inc. | 10/20/2011SE |
| K111376 | Construx External Fixation DeviceKTT · Traditional | Ebi, LLC | 08/03/2011SE |
| K110965 | Renovis T 710 Large External Fixation SystemKTT · Traditional | Renovis Surgical Technologies, LLC | 05/11/2011SE |
| K102843 | Mac Male AdapterKTT · Special | Biomet Trauma (Aka Ebi, LLC) | 05/03/2011SE |
| K103015 | Odrc-Dynamic Hip Screw SystemKTT · Traditional | Orthopaedic Device Research Center | 04/13/2011SE |
| K101338 | Newfix External Fixation SystemKTT · Traditional | Technologia Y Diseno Industrial, S.A DE C.V | 03/14/2011SE |
| K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareKTT · Special | Smith & Nephew, Inc. | 02/08/2011SE |
| K102057 | Targon FN SystemKTT · Traditional | Aesculap Implant Systems, LLC | 12/21/2010SE |
| K102688 | Merete Locking Bone Plate System IIKTT · Traditional | Merete Medical GmbH | 12/03/2010SE |
| K101759 | Quantum Ring Fixation System Model IsfKTT · Traditional | Quantum Medical Concepts, LLC | 10/22/2010SE |
| K093047 | Smith & Nephew Circular Fixation SystemKTT · Traditional | Smith & Nephew, Inc. | 09/27/2010SE |
| K101170 | Acute Innovations Sternal Fixation SystemKTT · Traditional | Acute Innovations, LLC | 09/17/2010SE |
| K100795 | Jet-X Bar System Clamps and Posts ReprocessingKTT · Traditional | Smith & Nephew, Inc. | 09/02/2010SE |
| K093753 | Mdpo Frame SystemKTT · Traditional | Mdpo, LLC | 08/26/2010SE |
| K100137 | Sidekick Circular Fixator System: Struts and HingesKTT · Special | Wrightmedicaltechnologyinc | 06/10/2010SE |
| K100857 | Fusion Medical Ring Lock SystemKTT · Traditional | John J Riccio | 05/27/2010SE |
| K092190 | Synthes Distraction Osteogenesis System, MR Conditional with Expanded IndicationsKTT · Traditional | Synthes (Usa) | 05/11/2010SE |
| K090658 | Synthes External Fixation Devices, MR ConditionalKTT · Traditional | Synthes (Usa) | 03/03/2010SE |
| K093550 | Mini Rail External Fixator SystemKTT · Special | Small Bone Innovations, Inc. | 01/07/2010SE |
| K092002 | Afghan External FixatorKTT · Traditional | Smith & Nephew, Inc. | 12/10/2009SE |
| K093057 | Biomet Vision Footring SystemKTT · Traditional | Ebi, L.P. | 12/01/2009SE |
| K092834 | Hoffman Xpress Line ExtensionKTT · Special | Howmedica Osteonics Corp. | 10/08/2009SE |
| K091619 | Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)KTT · Traditional | Anglefix | 09/08/2009SE |
| K083582 | Sign Hip Construct (SHC), Model: 701KTT · Traditional | Surgical Implant Generation Network (Sign) | 08/26/2009SE |
| K091258 | Extrafix External Fixation SystemKTT · Traditional | Qfx Technologies, Inc. | 07/24/2009SE |
| K090926 | Smith & Nephew Rail SystemKTT · Traditional | Smith & Nephew, Inc. | 06/08/2009SE |
| K090063 | Merete Locking Bone Plate SystemKTT · Traditional | Merete Medical, Inc. | 04/22/2009SE |
| K083789 | Ace Fischer External Fixation SystemKTT · Traditional | DePuy Orthopaedics, Inc. | 03/23/2009SE |
| K083636 | Reprocessed External Fixation DeviceKTT · Traditional | Sterilmed, Inc. | 03/02/2009SE |
| K082833 | NBX - Non-Bridging External Fixator - ShoulderKTT · Traditional | Nutek Orthopaedics, Inc. | 02/05/2009SE |
| K082650 | Synthes Large External Fixation, MR ConditionalKTT · Traditional | Synthes (Usa) | 11/18/2008SE |
| K081586 | Reprocessed External Fixation DeviceKTT · Traditional | Sterilmed, Inc. | 08/18/2008SE |
| K081342 | Reprocessed External Fixation AccessoriesKTT · Traditional | Sterilmed, Inc. | 08/13/2008SE |
| K081244 | Lower Extremity External Fixation - Expanded IndicationsKTT · Traditional | Biomet Trauma | 07/30/2008SE |
| K081284 | Variax Distal Fibula PlateKTT · Traditional | Howmedica Osteonics Corp. | 07/18/2008SE |
| K081278 | Omega 3 Trochanteric Stabilizing PlateKTT · Special | Howmedica Osteonics Corp. | 05/29/2008SE |
| K080408 | External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp…KTT · Traditional | Advanced Orthopaedic Solutions, Inc. | 04/25/2008SE |
| K072212 | Jet-X Bar System Clamps, Bars and Posts-Mr SafeKTT · Special | Smith & Nephew, Inc. | 03/07/2008SE |
| K073076 | Hoffmann Light SystemKTT · Traditional | Howmedica Osteonics Corp. | 02/15/2008SE |
| K073527 | Variax Elbow SystemKTT · Traditional | Howmedica Osteonics Corp. | 02/14/2008SE |
| K080071 | Sidekick Rail FixatorKTT · Special | Wrightmedicaltechnologyinc | 02/07/2008SE |
| K072250 | Supercable Grip and Plate SystemKTT · Traditional | Kinamed, Inc. | 11/09/2007SE |
| K071852 | Aap Aps SystemKTT · Traditional | Aap Implantate AG | 08/29/2007SE |
| K071395 | Biomet Vision Footring SystemKTT · Traditional | Biomet Manufacturing Corp | 07/09/2007SE |
| K071394 | Modification To:Sbi RingfixKTT · Special | Small Bone Innovations, Inc. | 06/29/2007SE |
| K070724 | Ios External Fixator, Model 2-0-0KTT · Traditional | Intelligent Orthopaedics, Ltd. | 05/16/2007SE |
| K070454 | Omega 3 Supracondylar PlateKTT · Special | Howmedica Osteonics Corp. | 04/12/2007SE |
| K070016 | Blue SharkKTT · Traditional | Meridan Medical | 04/02/2007SE |
| K063487 | Merete BLP Small Fragment Locking Bone PlateKTT · Traditional | Merete Medical GmbH | 01/22/2007SE |
| K063509 | Depuy Peak FX Hip PlateKTT · Traditional | DePuy Orthopaedics, Inc. | 01/04/2007SE |
| K063551 | Aequalis Humeral PlateKTT · Special | Tornier | 12/22/2006SE |
| K061759 | Reprocessed External Fixation DeviceKTT · Traditional | Ascent Healthcare Solutions | 09/05/2006SE |
| K062066 | Omega 3 SystemKTT · Special | Howmedica Osteonics Corp. | 08/15/2006SE |
| K061748 | Fragment Plate SystemKTT · Special | Hand Innovations, LLC | 07/17/2006SE |
| K060613 | Variax Locking Plate SystemKTT · Traditional | Howmedica Osteonics Corp. | 04/21/2006SE |
| K060545 | Unity Humeral PlateKTT · Traditional | Tornier | 04/21/2006SE |
| K052918 | Reprocessed External Fixation DevicesKTT · Traditional | Alliance Medical Corp. | 01/27/2006SE |
| K053472 | Hoffmann II MRI External Fixation SystemKTT · Special | Howmedica Osteonics Corp. | 01/11/2006SE |
| K053051 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | Vanguard Medical Concepts, Inc. | 12/22/2005SE |
| K053349 | Hoffmann II Rod to Wire CouplingKTT · Special | Howmedica Osteonics Corp. | 12/09/2005SE |
| K053038 | Hoffmann II Compact MRI External Fixation SystemKTT · Special | Howmedica Osteonics Corp. | 11/22/2005SE |
| K052196 | Vilex X-FixKTT · Traditional | Vilex, Inc. | 11/22/2005SE |
| K052605 | External FixationKTT · Traditional | Gexfix USA, Inc. | 11/10/2005SE |
| K052498 | Fragment Specific FixatorKTT · Traditional | David J. Slutsky MD | 10/17/2005SE |
| K052239 | Ebi Dynafix Vision Footplate SystemKTT · Traditional | Ebi, L.P. | 09/21/2005SE |
| K051957 | Reprocessed External Fixation DeviceKTT · Traditional | Sterilemed, Inc. | 09/21/2005SE |
| K052005 | R&R External Fixation SystemKTT · Traditional | R&R Medical, Inc. | 09/06/2005SE |
| K051616 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | Vanguard Medical Concepts, Inc. | 09/06/2005SE |
| K052064 | Alliance Medical Corporation Reprocessed External Fixation DevicesKTT · Special | Alliance Medical Corp. | 08/25/2005SE |
| K052062 | Alliance Medical Corporation Reprocessed External Fixation DevicesKTT · Special | Alliance Medical Corp. | 08/25/2005SE |
| K052065 | Alliance Medical Corporation Reprocessed External Fixation DevicesKTT · Special | Alliance Medical Corp. | 08/22/2005SE |
| K052037 | Modification to Hoffmann II Micro External Fixation SystemKTT · Special | Howmedica Osteonics Corp. | 08/05/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2833-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2832-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2831-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2830-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2829-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2828-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2827-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2732-2026 Class II | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2731-2026 Class II | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2730-2026 Class II | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2729-2026 Class II | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2513-2025 Class II | Medshape Universal Joints, REF: DNE-9000-UJBone external fixation system may have the pin that can become dislodged resulting in frame instability, the… | Medshape, INC. | 06/02/2025Open, Classified |
| Z-2219-2024 Class II | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.The adjustment ring on the device may become loose resulting in the wire tension not being able to be set… | Stryker GmbH | 05/09/2024Open, Classified |
| Z-1191-2023 Class II | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external…Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts.… | Stryker GmbH | 02/07/2023Open, Classified |
| Z-1102-2023 Class II | WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation…Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express… | Wishbone Medical, Inc. | 01/04/2023Open, Classified |
| Z-1678-2022 Class II | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BNManufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The… | OrthoPediatrics Corp | 06/29/2022Open, Classified |
| Z-0645-2022 Class II | Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110There is a potential for the outer Tyvek lid to de-bond from the sealed package. | Howmedica Osteonics Corp. | 12/21/2021Open, Classified |
| Z-0245-2022 Class II | Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21…Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners… | Medicalplastic S.R.L. | 06/17/2021Open, Classified |
| Z-1649-2022 Class II | Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System.…Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. | New Standard Device Inc | 12/28/2020Open, Classified |
| Z-1236-2022 Class II | 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire… | New Standard Device Inc | 06/08/2020Completed |
| Z-0327-2020 Class II | CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0326-2020 Class II | Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0528-2020 Class II | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-1824-2023 Class II | 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog…The threads on posts stripping out when tensioned during application process. | New Standard Device Inc | 07/23/2019Open, Classified |
| Z-0403-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0402-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0401-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0400-2020 Class II | ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0399-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0398-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0397-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0396-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0395-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0394-2020 Class II | ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI:…As a result of complaint investigations it was determined that batches of drill bits have a geometrical… | Orthofix Srl | 09/27/2018Terminated |
| Z-0291-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | Stryker GmbH | 08/28/2018Terminated |
| Z-0290-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | Stryker GmbH | 08/28/2018Terminated |
| Z-0289-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | Stryker GmbH | 08/28/2018Terminated |
| Z-0288-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | Stryker GmbH | 08/28/2018Terminated |
| Z-3240-2018 Class II | Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF…When creating a correction plan with the Correct Axial First button selected and the No. of corrections per… | Stryker GmbH | 07/26/2018Terminated |
| Z-1526-2018 Class II | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures…The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with… | Stryker GmbH | 03/12/2018Terminated |
| Z-2063-2018 Class II | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM…The firm received complaints regarding the incompatibility and dimensional interference between the double… | Orthofix Srl | 01/30/2018Terminated |
| Z-0291-2018 Class II | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and…The power drill torque limiter may break during use in surgery application. | Orthofix Srl | 07/05/2017Terminated |
| Z-2600-2017 Class II | 4.5 BROAD SCP PLT 26-H STERZimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package… | Zimmer Biomet, Inc. | 04/28/2017Terminated |
| Z-2594-2017 Class II | VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H…Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package… | Zimmer Biomet, Inc. | 04/28/2017Terminated |
| Z-2593-2017 Class II | VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22HZimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package… | Zimmer Biomet, Inc. | 04/28/2017Terminated |
| Z-2160-2017 Class II | Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC…Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut… | Stryker Howmedica Osteonics Corp. | 04/26/2017Terminated |
| Z-2387-2016 Class II | Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra…Through the investigation of reported complaints Integra verified that there have been instances where the… | Integra LifeSciences Corp. | 07/20/2016Terminated |
| Z-2386-2016 Class II | Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue…Through the investigation of reported complaints Integra verified that there have been instances where the… | Integra LifeSciences Corp. | 07/20/2016Terminated |
| Z-2296-2016 Class II | Integra External Fixation System Rocker Bottom Model # 12225400. For use in the…The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the… | Integra LifeSciences Corp. | 07/01/2016Terminated |
| Z-1682-2016 Class II | VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm)…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | Zimmer Manufacturing B.V. | 05/04/2016Terminated |