Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 33
- Latest Decision
- 2025-05-23
Clearances · page 7 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | MQV | Class II | 2025-05-23 |
| K250446 | Frida Anterior Cervical Plate System | Spineup, Inc. | KWQ | Class II | 2025-05-23 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | MAI | Class II | 2025-05-23 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | MBH | Class II | 2025-05-22 |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | TriMed, Inc. | HRS | Class II | 2025-05-22 |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | MEH | Class II | 2025-05-22 |
| K243116 | FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus | MAX | Class II | 2025-05-21 |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy | MAI | Class II | 2025-05-21 |
| K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | NKG | Class II | 2025-05-20 |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. | KWQ | Class II | 2025-05-20 |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | Restor3D | PHX | Class II | 2025-05-19 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | LZO | Class II | 2025-05-16 |
| K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | MQV | Class II | 2025-05-16 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | HRX | Class II | 2025-05-16 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical L.P. | PHX | Class II | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | LZO | Class II | 2025-05-15 |
| K250712 | Linkt Compression Staple System | Trax Surgical | JDR | Class II | 2025-05-14 |
| K242674 | Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. | NKG | Class II | 2025-05-13 |
| K243509 | Archer PSI System | 3D-Side | QHE | Class II | 2025-05-12 |
| K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | MBI | Class II | 2025-05-12 |
| K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | NKB | Class II | 2025-05-08 |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | JWH | Class II | 2025-05-08 |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | KTT | Class II | 2025-05-07 |
| K243043 | Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2025-05-02 |
| K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | HSN | Class II | 2025-05-01 |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | MEH | Class II | 2025-05-01 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | OVD | Class II | 2025-04-30 |
| K243963 | Pediatric Plating Platform Hip | OrthoPediatrics Corp. | HRS | Class II | 2025-04-29 |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | Eminent Spine | NKB | Class II | 2025-04-28 |
| K250554 | prodisc® L Instruments | Centinel Spine, LLC | QLQ | Class II | 2025-04-25 |
| K251075 | DYNAMIS Implant System | Promethean Restorative, LLC | OUR | Class II | 2025-04-25 |
| K250892 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | HRS | Class II | 2025-04-25 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | OVE | Class II | 2025-04-25 |
| K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | HRS | Class II | 2025-04-24 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | LPH | Class II | 2025-04-23 |
| K250155 | Xpert Knee | Newclip Technics | HRS | Class II | 2025-04-23 |
| K250669 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2025-04-22 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | OVD | Class II | 2025-04-22 |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | HSB | Class II | 2025-04-22 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | LZO | Class II | 2025-04-18 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | JWH | Class II | 2025-04-17 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | JDR | Class II | 2025-04-11 |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. | NDN | Class II | 2025-04-11 |
| K243943 | TriMed® Compression Screws | TriMed, Inc. | HWC | Class II | 2025-04-10 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | OVE | Class II | 2025-04-10 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | LPH | Class II | 2025-04-10 |
| K250112 | FitboneTM Trochanteric | Orthofix Srl | HSB | Class II | 2025-04-10 |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | KWQ | Class II | 2025-04-10 |
| K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2025-04-09 |
| K250948 | TriMed Fusion Cup System | TriMed, Inc. | HRS | Class II | 2025-04-08 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | MQV | Class II | 2025-04-07 |
| K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | MAX | Class II | 2025-04-04 |
| K250332 | Virage® OCT Spinal Fixation System | Highridge Medical, LLC | NKG | Class II | 2025-04-04 |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | MAX | Class II | 2025-04-04 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | MAI | Class II | 2025-04-03 |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | HWC | Class II | 2025-04-02 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | JWH | Class II | 2025-04-02 |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | LOD | Class II | 2025-04-02 |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | HSB | Class II | 2025-04-01 |
| K250596 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2025-03-28 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | LZO | Class II | 2025-03-28 |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | MBH | Class II | 2025-03-27 |
| K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | NKB | Class II | 2025-03-27 |
| K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | HRS | Class II | 2025-03-26 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | OVD | Class II | 2025-03-24 |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | JWH | Class II | 2025-03-24 |
| K242356 | TIDAL Fusion Cage System | Restor3D, Inc. | SAI | Class II | 2025-03-24 |
| K250186 | GoLIF! Lumbar Interbody Fusion System | Getset Surgical, SA | MAX | Class II | 2025-03-21 |
| K250556 | Porous Biologic Scaffold | Ventris Medical | MQV | Class II | 2025-03-21 |
| K250403 | Catamaran SI Joint Fusion System | Tenon Medical | OUR | Class II | 2025-03-21 |
| K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | MAX | Class II | 2025-03-20 |
| K243988 | RootMend MRR | Riverpoint Medical, LLC | MBI | Class II | 2025-03-20 |
| K243987 | TriMed Elbow and Forearm System | TriMed, Inc. | HRS | Class II | 2025-03-19 |
| K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | HRS | Class II | 2025-03-19 |
| K243999 | TriMed Ankle Fixation System | TriMed, Inc. | HRS | Class II | 2025-03-19 |
| K250494 | The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies | HRS | Class II | 2025-03-18 |
| K241783 | FortiVy OsteoVy Lumbar IBF | Vy Spine, LLC | MAX | Class II | 2025-03-18 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | 2025-03-17 |
| K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | HRS | Class II | 2025-03-17 |
| K241816 | VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. | PGM | Class II | 2025-03-14 |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. | MAI | Class II | 2025-03-14 |
| K243838 | NEXXT MATRIXX® SI System | Nexxt Spine | OUR | Class II | 2025-03-14 |
| K241811 | MedCAD® AccuStride System | Medcad | PBF | Class II | 2025-03-13 |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | JWH | Class II | 2025-03-13 |
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | ODP | Class II | 2025-03-12 |
| K250424 | Arthrex TightRope Soft Button, RT | Arthrex, Inc. | MBI | Class II | 2025-03-11 |
| K243029 | Origin TT Stem | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2025-03-11 |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | MEH | Class II | 2025-03-10 |
| K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | KWT | Class II | 2025-03-10 |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | HRS | Class II | 2025-03-07 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | KTT | Class II | 2025-03-07 |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Zimmer, Inc. | JWH | Class II | 2025-03-06 |
| K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | QNI | Class II | 2025-03-06 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | LZO | Class II | 2025-03-06 |
| K250304 | TITANEX Screw Systems | Vilex, LLC | HWC | Class II | 2025-03-05 |
| K243809 | Biolox® Delta Revision heads | Limacorporate | LZO | Class II | 2025-03-04 |
| K244039 | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | JWH | Class II | 2025-02-28 |
| K243565 | DYNAMIS SI Screw System | Promethean Restorative, LLC | OUR | Class II | 2025-02-28 |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | NKB | Class II | 2025-02-27 |
| K243357 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | HRS | Class II | 2025-02-27 |
17,115 clearances in the Orthopedic panel. Data: openFDA.