Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 41
- Latest Decision
- 2025-11-19
Clearances · page 5 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | JWH | Class II | 2025-11-19 |
| K242603 | MyPAO SA guides | Medacta International S.A. | PBF | Class II | 2025-11-19 |
| K252729 | Universal Spinal System | Double Medical Technology, Inc. | NKB | Class II | 2025-11-18 |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | HRS | Class II | 2025-11-18 |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | HRS | Class II | 2025-11-14 |
| K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2025-11-13 |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | LPH | Class II | 2025-11-12 |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | NKG | Class II | 2025-11-12 |
| K252959 | WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A | HRS | Class II | 2025-11-12 |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. | PLR | Class II | 2025-11-10 |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | KWS | Class II | 2025-11-06 |
| K251555 | Ultra Compression Screw System | Pace Surgical | HWC | Class II | 2025-11-06 |
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | MEH | Class II | 2025-11-05 |
| K251709 | MedCAD® AccuStride System | Medcad | PBF | Class II | 2025-11-04 |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | MBI | Class II | 2025-11-04 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | HRX | Class II | 2025-11-03 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | MBH | Class II | 2025-10-31 |
| K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | PHX | Class II | 2025-10-31 |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | KWT | Class II | 2025-10-30 |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | HTN | Class II | 2025-10-29 |
| K252314 | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2025-10-29 |
| K253314 | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | JWH | Class II | 2025-10-29 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | KWS | Class II | 2025-10-29 |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | PHX | Class II | 2025-10-29 |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | JDW | Class II | 2025-10-29 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | MAX | Class II | 2025-10-28 |
| K253300 | Fine Osteotomy | Bodycad Laboratories, Inc. | HRS | Class II | 2025-10-28 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | MBH | Class II | 2025-10-24 |
| K253335 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2025-10-24 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | MAX | Class II | 2025-10-24 |
| K253129 | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | NKG | Class II | 2025-10-24 |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | NKB | Class II | 2025-10-24 |
| K253144 | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | JWH | Class II | 2025-10-22 |
| K252322 | SIros-X System | Genesys Spine | OUR | Class II | 2025-10-22 |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | 2025-10-22 |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | NKB | Class II | 2025-10-21 |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | MBI | Class II | 2025-10-21 |
| K253249 | TriALTIS Spine System | Medos International SARL | NKB | Class II | 2025-10-21 |
| K250394 | Fine TTO | Bodycad Laboratories, Inc. | PBF | Class II | 2025-10-21 |
| K242827 | A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. | NKB | Class II | 2025-10-20 |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | PLF | Class II | 2025-10-17 |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | HSB | Class II | 2025-10-17 |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | MAI | Class II | 2025-10-15 |
| K252920 | ELEOS Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | QZZ | Class II | 2025-10-15 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | HRX | Class II | 2025-10-15 |
| K253010 | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | MBI | Class II | 2025-10-14 |
| K253331 | PressON Spinal Fixation System | Nexus Spine | NKB | Class II | 2025-10-14 |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Bone Solutions, Inc. | MQV | Class II | 2025-10-13 |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | ODP | Class II | 2025-10-10 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | HWC | Class II | 2025-10-10 |
| K252600 | Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. | HRS | Class II | 2025-10-09 |
| K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | OUR | Class II | 2025-10-09 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | HWC | Class II | 2025-10-08 |
| K250894 | Eminent Spine Posterior SI System | Eminent Spine | OUR | Class II | 2025-10-07 |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | PKC | Class II | 2025-10-03 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | HWC | Class II | 2025-10-02 |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | 2025-10-01 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | KTT | Class II | 2025-09-30 |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | MQV | Class II | 2025-09-30 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | HRX | Class II | 2025-09-29 |
| K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | PHX | Class II | 2025-09-26 |
| K250076 | Endeavor Stand-Alone Cervical IBF System | Innovasis | OVE | Class II | 2025-09-25 |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | PLF | Class II | 2025-09-25 |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | JWH | Class II | 2025-09-25 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | HTY | Class II | 2025-09-19 |
| K250450 | Coated hip implants | Medacta International S.A. | LZO | Class II | 2025-09-19 |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | MAX | Class II | 2025-09-18 |
| K252615 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | QWL | Class II | 2025-09-17 |
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | MBB | Class II | 2025-09-15 |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | HSB | Class II | 2025-09-12 |
| K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. | QGQ | Class II | 2025-09-11 |
| K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos Medical GmbH | HRS | Class II | 2025-09-08 |
| K250095 | All-Suture Dual Anchor System | Suturetech, Inc. | MBI | Class II | 2025-09-05 |
| K251444 | Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2025-09-04 |
| K252454 | Kinos Total Ankle System | Restor3D | HSN | Class II | 2025-09-03 |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine | OVD | Class II | 2025-09-03 |
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | NJD | Class II | 2025-09-02 |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | HWC | Class II | 2025-08-29 |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | ODP | Class II | 2025-08-29 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | LPH | Class II | 2025-08-29 |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | PHX | Class II | 2025-08-28 |
| K252437 | JAZZ Spinal System | Implanet | NKB | Class II | 2025-08-28 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | KWQ | Class II | 2025-08-28 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | HRX | Class II | 2025-08-27 |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | HWC | Class II | 2025-08-27 |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | KWY | Class II | 2025-08-25 |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | KRO | Class II | 2025-08-22 |
| K250923 | Fine Osteotomy | Bodycad Laboratories, Inc. | HRS | Class II | 2025-08-21 |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | HRS | Class II | 2025-08-21 |
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | Acumed, LLC | HRS | Class II | 2025-08-21 |
| K252061 | Distal Xtremities System | TriMed, Inc. | HRS | Class II | 2025-08-20 |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | HSB | Class II | 2025-08-20 |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | MAI | Class II | 2025-08-19 |
| K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | HRS | Class II | 2025-08-18 |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies | HRS | Class II | 2025-08-16 |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. | MAX | Class II | 2025-08-15 |
| K251834 | Persona Partial Knee | Zimmer Biomet | HSX | Class II | 2025-08-15 |
| K250620 | KLS Martin Ixos System | KLS Martin L.P. | HRS | Class II | 2025-08-15 |
| K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | HWC | Class II | 2025-08-15 |
| K243905 | Stitch Cerclage Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | JDQ | Class II | 2025-08-14 |
17,115 clearances in the Orthopedic panel. Data: openFDA.