Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2026-04-27
Clearances · page 3 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260660 | SABER-C System | Elevation Spine | OVE | Class II | 2026-04-27 |
| K261032 | NovoKnee (SteriKnee) | NovoSource | JWH | Class II | 2026-04-27 |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. | LZO | Class II | 2026-04-27 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | HRS | Class II | 2026-04-24 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | HRS | Class II | 2026-04-24 |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | Stryker Spine | MQV | Class II | 2026-04-24 |
| K261043 | AUTOBAHN Nailing System | Globus Medical, Inc. | HSB | Class II | 2026-04-24 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | ODP | Class II | 2026-04-24 |
| K252451 | EPORE® XO cup system | Implantcast GmbH | OQI | Class II | 2026-04-24 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | HRS | Class II | 2026-04-24 |
| K260570 | corra cervical plating system | Carlsmed, Inc. | KWQ | Class II | 2026-04-22 |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2026-04-21 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | MBI | Class II | 2026-04-21 |
| K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | OVE | Class II | 2026-04-20 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | KTT | Class II | 2026-04-17 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | HWC | Class II | 2026-04-17 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | NKB | Class II | 2026-04-16 |
| K253260 | ORIO-3D Cage System | SpineCraft | ODP | Class II | 2026-04-16 |
| K253523 | Freedom DS Decompression System | Spinal Simplicity | HRX | Class II | 2026-04-16 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | OVE | Class II | 2026-04-15 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | PHX | Class II | 2026-04-15 |
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | LOD | Class II | 2026-04-15 |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | PHX | Class II | 2026-04-14 |
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | KWY | Class II | 2026-04-13 |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | MBF | Class II | 2026-04-13 |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | PHX | Class II | 2026-04-13 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | ODP | Class II | 2026-04-13 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | HWC | Class II | 2026-04-10 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | HRS | Class II | 2026-04-10 |
| K260477 | CATAMARAN SI Joint Fusion System | Tenon Medical | OUR | Class II | 2026-04-08 |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | KWS | Class II | 2026-04-06 |
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | KWD | Class II | 2026-04-03 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2026-04-03 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | HWC | Class II | 2026-04-03 |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | PHX | Class II | 2026-04-03 |
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | HSX | Class II | 2026-04-02 |
| K242303 | MOD-C | Orthomod, LLC | ODP | Class II | 2026-04-01 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | HRS | Class II | 2026-04-01 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | LZO | Class II | 2026-03-30 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | ODP | Class II | 2026-03-30 |
| K252064 | MedCAD® AccuStride System | Medcad | PBF | Class II | 2026-03-27 |
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | HTN | Class II | 2026-03-27 |
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | MAI | Class II | 2026-03-27 |
| K253392 | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | QLQ | Class II | 2026-03-27 |
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | KWQ | Class II | 2026-03-27 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | HRS | Class II | 2026-03-25 |
| K252432 | Flex-Z Cervical Cage | Spinepoint, LLC | ODP | Class II | 2026-03-25 |
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | OWI | Class II | 2026-03-25 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | HRS | Class II | 2026-03-25 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | HRS | Class II | 2026-03-24 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | HRS | Class II | 2026-03-23 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | KTT | Class II | 2026-03-23 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | HSB | Class II | 2026-03-20 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2026-03-20 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | HRS | Class II | 2026-03-19 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | HSB | Class II | 2026-03-18 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | HWC | Class II | 2026-03-18 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | HRS | Class II | 2026-03-17 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | MBI | Class II | 2026-03-17 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2026-03-17 |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | NKG | Class II | 2026-03-16 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | HRS | Class II | 2026-03-16 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | MBI | Class II | 2026-03-16 |
| K252401 | implaFit® short stems | Implantcast GmbH | LZO | Class II | 2026-03-12 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | HRX | Class II | 2026-03-12 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | JDI | Class II | 2026-03-12 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | HSB | Class II | 2026-03-12 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | MBI | Class II | 2026-03-12 |
| K253906 | Xpert Hand | Newclip Technics | HRS | Class II | 2026-03-11 |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | MBI | Class II | 2026-03-11 |
| K253624 | INHANCE Reverse Shoulder System | Depuy Ireland UC | PHX | Class II | 2026-03-11 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | HSB | Class II | 2026-03-10 |
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | Synthes GmbH | HRS | Class II | 2026-03-10 |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | HRS | Class II | 2026-03-09 |
| K260405 | FiberTape Button | Arthrex, Inc. | MBI | Class II | 2026-03-09 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | MBH | Class II | 2026-03-09 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | 2026-03-06 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | MBI | Class II | 2026-03-06 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | HSB | Class II | 2026-03-05 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | HSB | Class II | 2026-03-05 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | KWQ | Class II | 2026-03-04 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | HSB | Class II | 2026-03-04 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | MBI | Class II | 2026-03-04 |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | HRS | Class II | 2026-03-03 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2026-03-03 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2026-03-02 |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | HRS | Class II | 2026-03-02 |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | HRS | Class II | 2026-02-27 |
| K253695 | LigaMend | Riverpoint Medical, LLC | MBI | Class II | 2026-02-27 |
| K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | OSN | Class II | 2026-02-26 |
| K254182 | Aster | Osteonic Co., Ltd. | KWQ | Class II | 2026-02-26 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | MBH | Class II | 2026-02-26 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | MAX | Class II | 2026-02-26 |
| K252166 | RIB LINK Fixation System | Globus Medical, Inc. | HRS | Class II | 2026-02-26 |
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | PQC | Class II | 2026-02-25 |
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | OVD | Class II | 2026-02-25 |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | MAI | Class II | 2026-02-24 |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | NKB | Class II | 2026-02-24 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | MAX | Class II | 2026-02-23 |
| K253169 | Duet Spinal Fixation System | Box Spine, LLC | NKB | Class II | 2026-02-23 |
17,115 clearances in the Orthopedic panel. Data: openFDA.