| MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087) | Synthes (USA) Products, LLC | 2026-06-11 |
| DYNEX® External Fixation Systems (K260900) | Vilex, LLC | 2026-04-17 |
| QuikFix External Fixator: Knee-Spanning Pack (K260112) | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| Excelsior System (K253291) | Blue Ocean Global | 2026-01-20 |
| Hoffmann LRF System (K253202) | Stryker GmbH | 2025-12-19 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |
| Medusa Orthopedics Boa External Fixation System (K252555) | Medusa Orthopedics, LLC | 2025-11-25 |
| The Response Ortho Smart Fixator - Hexapod System (K252625) | Response Ortho Solutions, LLC | 2025-11-20 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) | Amdt Holdings, Inc. | 2025-08-08 |
| Extremity Medical External Fixation System (K251128) | Extremity Medical, LLC | 2025-05-07 |
| Orthex External Fixation System (K243798) | OrthoPediatrics Corp. | 2025-03-07 |
| Extremity Medical External Fixation System (K241563) | Extremity Medical, LLC | 2025-02-21 |
| TrueLok Elevate (K242861) | Orthofix Srl | 2024-12-03 |
| Monkey Bars Pin to Bar External Fixation System (K242452) | Paragon 28, Inc. | 2024-11-01 |
| Response Ortho Metaphyseal Hinge Fixator System (K241769) | Response Ortho Solutions, LLC | 2024-09-18 |
| Revolution External Plating System (K233025) | New Standard Device Dba Metalogix | 2024-05-30 |
| LINK(TM) External Fixator (K240049) | Metric Medical Devices, Inc. | 2024-05-29 |
| Hoffmann LRF System (K233741) | Stryker GmbH | 2023-12-21 |
| Auxein's DHS/DCS Plate System (K221787) | Auxein Medical Private Limited | 2023-11-30 |
| Arthrex Small External Fixation System (K232897) | Arthrex, Inc. | 2023-10-18 |
| Monkey RingsTM External Fixation System (K232838) | Paragon 28, Inc. | 2023-10-12 |
| DEPUY SYNTHES MAXFRAME AUTOSTRUT System (K231922) | DePuy Synthes | 2023-07-26 |
| Smart Correction System (HA Half Pins) (K231461) | Wishbone Medical, Inc. | 2023-06-16 |
| Orthex External Fixation System (K223786) | OrthoPediatrics Corp. | 2023-02-10 |
| ONX Large External Fixation System (K213905) | Orthonovis, Inc. | 2022-08-25 |
| Smart Correction System Rings and Compatible HA-Coated Half Pins (K221366) | Wishbone Medical, Inc. | 2022-06-06 |
| Drive Rail System (K220809) | OrthoPediatrics Corp. | 2022-04-08 |
| Paragon 28 External Ring Fixation System (K212895) | Paragon 28, Inc. | 2021-11-08 |
| TrueLok Evo (K212044) | Orthofix Srl | 2021-11-05 |
| Correx Software (K212552) | Vilex, LLC | 2021-10-12 |
| SMART Taylor Spatial Frame (K210953) | Smith & Nephew, Inc. | 2021-07-29 |
| MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (K211313) | Synthes (USA) Products, LLC | 2021-05-25 |
| OIC External Fixation System (K211112) | Orthopaedic Implant Company | 2021-05-05 |
| Hoffmann LRF System (K203568) | Stryker GmbH | 2021-02-01 |
| Sequel External Fixation Device (K202833) | Sequel Medical, Inc. | 2021-01-19 |
| AutoStrut G2 (K202810) | Orthospin, Ltd. | 2021-01-06 |
| Bfix Orthopedic External Fixator Systems (K200491) | Aike (Shanghai) Medical Instrument Co., Ltd. | 2021-01-05 |
| Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (K201253) | Smith & Nephew | 2020-12-08 |
| Circular Fixation with Balanced Cable Transport (K202762) | Smith & Nephew, Inc. | 2020-11-16 |
| Pitkar DeftFix System (K200728) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-10-06 |
| Accessories for the SixFix® Hexapod Fixator (K200123) | Arrowhead De, LLC | 2020-09-22 |
| Smart Correction System (K193368) | Wishbone Medical, Inc. | 2020-09-18 |
| FusionFrame Ring Lock System (K200343) | Glw Medical Innovation | 2020-09-14 |
| Dynex Micro (K202143) | Vilex, LLC | 2020-09-11 |
| Dynex Ring Fixation System, Diametrix Ring Fixation System (K202054) | Vilex, LLC | 2020-08-24 |
| Pitkar External Fixation System - Rail Mechanism (K200518) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-07-29 |
| PRECICE Plating System (K192181) | Nuvasive Specialized Orthopedics, Inc. | 2019-11-07 |
| Pitkar External Fixation System (K190486) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2019-10-16 |
| AutoStrut (K191241) | Orthospin | 2019-08-14 |
| Revolution External Plating System (K181630) | New Standard Device Dba Metalogix | 2019-05-29 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K190069) | Arrowhead De, LLC | 2019-05-14 |
| OIC External Fixation System (K183682) | Orthopaedic Implant Company | 2019-04-08 |
| Austin Miller Large External Fixation System (K181528) | Austin Miller Trauma, LLC | 2019-02-28 |
| Hoffmann LRF System (K182968) | Stryker GmbH | 2019-01-25 |
| Depuy Synthes Femoral Neck System (K182154) | Synthes (USA) Products, LLC | 2018-10-16 |
| External Fixation System (K173883) | Life Spine, Inc. | 2018-09-07 |
| Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices (K180580) | Surgical Instrument Service and Savings, Inc. | 2018-07-27 |
| SALVATION External Fixation System (K180832) | Wrightmedicaltechnologyinc | 2018-06-06 |
| DePuy Synthes Femoral Neck System (K172872) | DePuy Synthes | 2018-03-05 |
| ARBOR External Fixation System (K172438) | Globus Medical, Inc. | 2018-01-12 |
| Medline ReNewal Reprocessed Synthes External Fixation Systems (K171911) | Surgical Instrument Service and Savings, Inc. | 2017-11-09 |
| Galaxy UNYCO System (K170146) | Orthofix Srl | 2017-10-12 |
| Spider Frame External Fixation System (K170482) | Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S | 2017-09-27 |
| OIC External Fixation System (K171211) | Orthopaedic Implant Company | 2017-09-27 |
| The Locking Pediatric Osteotomy Plate (LolliPOP) System (K170704) | Pega Medical, Inc. | 2017-09-08 |
| DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates (K163486) | Hnm Total Recon, LLC | 2017-07-24 |
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (K170650) | Orthofix Srl | 2017-05-10 |
| Hoffmann LRF System (K163656) | Stryker GmbH | 2017-04-14 |
| Dolphix® External Fixation System MR Conditional (K163323) | Citieffe S.R.L. | 2017-03-20 |
| SALVATION External Fixation System (K162033) | Wright Medical | 2017-03-06 |
| Arrowhead Mini-Rail Fixator (K162032) | Arrowhead De, LLC | 2017-02-21 |
| Gexfix External Fixation (K160972) | Gexfix International Corp. | 2016-12-28 |
| Hoffman LRF System (K161753) | Stryker GmbH | 2016-11-15 |
| DePuy Synthes MAXFRAME Multi-Axial Correction System (K161417) | Synthes USA, LLC | 2016-11-10 |
| Integra External Fixation System (K160830) | Ascension Orthopedics | 2016-07-06 |
| Hoffmann LRF (Limb Reconstruction Frame) System (K153377) | Stryker GmbH | 2016-04-11 |
| X-Fix Line Additions (K151881) | Vilex IN Tennessee, Inc. | 2016-03-24 |
| D.N.E. External Fixation System (K151580) | Dne, LLC | 2016-02-16 |
| SALVATION(R) External Fixation System (K153635) | Wrightmedicaltechnologyinc | 2016-01-13 |
| Reprocessed Stryker External Fixation Devices (K153415) | Stryker Sustainability Solutions | 2016-01-13 |
| Galaxy UNYCO System (K153233) | Orthofix Srl | 2016-01-06 |
| Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables (K151907) | Zimmer, Inc. | 2015-12-30 |
| FastFrame External Fixation System-Ankle Spanning (K152755) | Zimmer, Inc. | 2015-12-21 |
| FastFrame External Fixation System - Distal Radius (K152484) | Zimmer, Inc. | 2015-12-04 |
| RX-FIX Mini Rail External Fixator (K150640) | Wrightmedicaltechnologyinc | 2015-12-01 |
| FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control (K151992) | Zimmer, Inc. | 2015-11-02 |
| Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (K152171) | Orthofix Srl | 2015-09-28 |
| ARIX Ankle System (K152158) | Jeil Medical Corporation | 2015-09-28 |
| SALVATION® External Fixation System (K152045) | Wrightmedicaltechnologyinc | 2015-08-21 |
| Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System (K150818) | Zimmer, Inc. | 2015-05-01 |
| Cardinal Health External Fixation System (K150579) | Cardinalhealth | 2015-04-29 |
| SALVATION External Fixation System (K150004) | Wrightmedicaltechnologyinc | 2015-03-04 |
| SIDEKICK EZ FRAME External Fixation System (K143220) | Wrightmedicaltechnologyinc | 2015-01-08 |
| Orthofix True Lok Hexapod System VI.3 (K143125) | Orthofix Srl | 2014-12-10 |
| ORTHOFIX GALAXY WRIST (K141760) | Orthofix Srl | 2014-12-08 |
| ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT (K142052) | Orthofix Srl | 2014-12-05 |
| Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software (K142520) | Smith & Nephew, Inc. | 2014-11-20 |
| HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K140961) | Stryker Trauma AG | 2014-11-10 |