Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2025-02-26
Clearances · page 8 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K250346 | BonVie+ | Elute, Inc. | MQV | Class II | 2025-02-26 |
| K250238 | WasherCap Fixation System | Abanza Tecnomed S.L | MBI | Class II | 2025-02-25 |
| K241983 | Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical | HSB | Class II | 2025-02-21 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | KTT | Class II | 2025-02-21 |
| K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | NKB | Class II | 2025-02-21 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | MQV | Class II | 2025-02-21 |
| K241470 | CORE Shoulder System | LinkBio Corp. | QHE | Class II | 2025-02-20 |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | JDQ | Class II | 2025-02-20 |
| K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew | HRS | Class II | 2025-02-19 |
| K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | HRS | Class II | 2025-02-19 |
| K244015 | SuperBall-RC | Arcuro Medical , Ltd. | MBI | Class II | 2025-02-19 |
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | ODP | Class II | 2025-02-18 |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | JWH | Class II | 2025-02-18 |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | 2025-02-13 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | MBH | Class II | 2025-02-13 |
| K243907 | Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. | HSB | Class II | 2025-02-12 |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | OVE | Class II | 2025-02-11 |
| K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | KWT | Class II | 2025-02-11 |
| K240958 | Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. | HRS | Class II | 2025-02-10 |
| K241483 | ceramys femoral head system | Encore Medical L.P. | LZO | Class II | 2025-02-07 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | OVE | Class II | 2025-02-07 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH | Class II | 2025-02-06 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH | Class II | 2025-02-06 |
| K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty , Ltd. | HRS | Class II | 2025-02-06 |
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. | HRS | Class II | 2025-02-06 |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | Depuy Mitek | MAI | Class II | 2025-02-05 |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | HWC | Class II | 2025-02-05 |
| K243908 | Tiger 2 System | Zavation Medical Products, LLC | NKB | Class II | 2025-02-03 |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Alphatec Spine | MAX | Class II | 2025-02-03 |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | ZheJiang Decans Medical Devices Co., Ltd. | MBI | Class II | 2025-01-31 |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | JDR | Class II | 2025-01-31 |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | HWC | Class II | 2025-01-31 |
| K243712 | WasherCap Mini Fixation System (Model 45) | Abanza Tecnomed S.L | MBI | Class II | 2025-01-30 |
| K243726 | Osprey Suture Anchor | Responsive Arthroscopy, Inc. | MBI | Class II | 2025-01-30 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | KWS | Class II | 2025-01-30 |
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | ODP | Class II | 2025-01-29 |
| K243740 | Versalock Upper Limb Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2025-01-29 |
| K244025 | Argo Knotless GENESYS Anchor | Conmed Corporation | MBI | Class II | 2025-01-28 |
| K243739 | AxCess® Expandable Interbody System | Elliquence, LLC | MAX | Class II | 2025-01-24 |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | HTN | Class II | 2025-01-23 |
| K243668 | ProLift Pivot Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2025-01-23 |
| K241234 | OTS 25-L (100-5) | Ots Medical , Ltd. | MBI | Class II | 2025-01-23 |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | LPH | Class II | 2025-01-22 |
| K241357 | XT3 System | Biodynamik, Inc. | JDW | Class II | 2025-01-22 |
| K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | QHE | Class II | 2025-01-21 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. | MQV | Class II | 2025-01-17 |
| K243249 | TriALTIS Spine System | Medos International SARL | NKB | Class II | 2025-01-17 |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | TriMed, Inc. | HRS | Class II | 2025-01-15 |
| K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | NKB | Class II | 2025-01-15 |
| K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies | JWH | Class II | 2025-01-14 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | KWQ | Class II | 2025-01-14 |
| K243890 | Arthrex Intramedullary Nails | Arthrex, Inc. | HSB | Class II | 2025-01-13 |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | JWH | Class II | 2025-01-13 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | LPH | Class II | 2025-01-13 |
| K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | HWC | Class II | 2025-01-10 |
| K243477 | Universal Tendon Spacer | Askorn Medical | HXA | Class II | 2025-01-10 |
| K243259 | MASADA Modular Spinal Fixation System | Astura Medical | NKB | Class II | 2025-01-07 |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corporation | LZO | Class II | 2025-01-06 |
| K243670 | Idys® LIF | Clariance | MAX | Class II | 2024-12-31 |
| K243835 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2024-12-27 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | JDR | Class II | 2024-12-26 |
| K242782 | GlassBone Granules | Noraker | MQV | Class II | 2024-12-23 |
| K243248 | INHANCE INTACT | Depuy Ireland UC | PKC | Class II | 2024-12-23 |
| K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | MQV | Class II | 2024-12-23 |
| K242091 | Bolo Button System | Fusion Orthopedics | HTN | Class II | 2024-12-23 |
| K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | HRS | Class II | 2024-12-23 |
| K243693 | NEO Pedicle Screw System | Neo Medical SA | NKB | Class II | 2024-12-23 |
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | JWH | Class II | 2024-12-20 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | MBH | Class II | 2024-12-20 |
| K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | Bonebridge AG | HRS | Class II | 2024-12-20 |
| K242529 | Tigon Medical All-Suture Anchors (ASA) | Tigon Medical | MBI | Class II | 2024-12-20 |
| K241167 | BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical | MQV | Class II | 2024-12-20 |
| K240765 | Porous Biologic Scaffold | Ventris Medical | MQV | Class II | 2024-12-18 |
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | Etex Corporation | MQV | Class II | 2024-12-18 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | MBH | Class II | 2024-12-18 |
| K242216 | GENTAFIX® (1, 3, 3MV) | Teknimed Sas | MBB | Class II | 2024-12-18 |
| K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | 2024-12-17 |
| K242869 | prodisc® L Instruments | Centinel Spine, LLC | QLQ | Class II | 2024-12-17 |
| K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | NJD | Class II | 2024-12-16 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | 2024-12-13 |
| K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | NKB | Class II | 2024-12-13 |
| K243491 | SternalPlate Expansion | Stryker Leibinger GmbH & Co KG | HRS | Class II | 2024-12-11 |
| K243369 | Cervical Plating System | Life Spine, Inc. | KWQ | Class II | 2024-12-11 |
| K242417 | VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | HRX | Class II | 2024-12-11 |
| K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | PKC | Class II | 2024-12-11 |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | HSB | Class II | 2024-12-09 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | KWS | Class II | 2024-12-06 |
| K241260 | ACTIFY Unicondylar Knee System | Globus Medical, Inc. | HSX | Class II | 2024-12-06 |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. | MAX | Class II | 2024-12-06 |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | PLF | Class II | 2024-12-06 |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | MQV | Class II | 2024-12-05 |
| K241674 | OSTEOPAL® V | Heraeus Medical GmbH | LOD | Class II | 2024-12-05 |
| K243444 | BIOCERAM AZUL® HEAD | Kyocera Corporation | LZO | Class II | 2024-12-05 |
| K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | HRS | Class II | 2024-12-05 |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH | Class II | 2024-12-04 |
| K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | HWC | Class II | 2024-12-04 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | MAI | Class II | 2024-12-03 |
| K242861 | TrueLok Elevate | Orthofix Srl | KTT | Class II | 2024-12-03 |
| K243470 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | MBI | Class II | 2024-12-03 |
| K243020 | MIDASVu | Intravu, Inc. | HRX | Class II | 2024-12-02 |
17,115 clearances in the Orthopedic panel. Data: openFDA.