Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2025-08-13
Clearances · page 6 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | HSB | Class II | 2025-08-13 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | KTT | Class II | 2025-08-11 |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | MBF | Class II | 2025-08-11 |
| K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | KTT | Class II | 2025-08-08 |
| K250540 | SABER-C System | Elevation Spine | OVE | Class II | 2025-08-08 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2025-08-07 |
| K250622 | Succession AFN System | Ortho Solutions UK , Ltd. | HSB | Class II | 2025-08-07 |
| K252326 | InterSpace GV Hip Spacer | Tecres S.P.A. | KWL | Class II | 2025-08-06 |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | MBI | Class II | 2025-08-06 |
| K252141 | AltiVate Reverse® Glenoid | Encore Medical L.P. | PHX | Class II | 2025-08-05 |
| K252113 | PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices | MAX | Class II | 2025-08-05 |
| K243448 | Equinoxe® Shoulder System | Exactech, Inc. | PHX | Class II | 2025-08-01 |
| K250315 | RONAVIS FX (FX-001) | AIRS, Inc. | HTY | Class II | 2025-08-01 |
| K241461 | Mpact Constrained Liner | Medacta International S.A. | KWZ | Class II | 2025-07-31 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | JDI | Class II | 2025-07-31 |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | United Orthopedic Corporation | MBH | Class II | 2025-07-31 |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical | MBI | Class II | 2025-07-30 |
| K251361 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | HRS | Class II | 2025-07-30 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | HRX | Class II | 2025-07-30 |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | OVE | Class II | 2025-07-30 |
| K250647 | SImmetry+ System | Sivantage | OUR | Class II | 2025-07-29 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | LPH | Class II | 2025-07-25 |
| K251620 | A.L.P.S. Proximal Humerus Plating System | Zimmer Biomet | HRS | Class II | 2025-07-25 |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO | Class II | 2025-07-25 |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | HSX | Class II | 2025-07-24 |
| K251310 | OTS 25-L (100-5) | Ots Medical , Ltd. | MBI | Class II | 2025-07-22 |
| K250952 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | HRS | Class II | 2025-07-18 |
| K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2025-07-18 |
| K251906 | Z1 Hip System | Zimmer, Inc. | LZO | Class II | 2025-07-18 |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | MQV | Class II | 2025-07-17 |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | MAX | Class II | 2025-07-17 |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | HSB | Class II | 2025-07-14 |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Acumed, LLC | HRS | Class II | 2025-07-14 |
| K251554 | Materialise TKA Guide System | Materialise NV | JWH | Class II | 2025-07-14 |
| K251134 | RipCord | TriMed, Inc. | HTN | Class II | 2025-07-11 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | KWQ | Class II | 2025-07-11 |
| K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | MBI | Class II | 2025-07-10 |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. | OVD | Class II | 2025-07-10 |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. | HRS | Class II | 2025-07-10 |
| K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | OUR | Class II | 2025-07-09 |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2025-07-08 |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | JWH | Class II | 2025-07-08 |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2025-07-08 |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. | MAX | Class II | 2025-07-07 |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | MAX | Class II | 2025-07-07 |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | ODP | Class II | 2025-07-03 |
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | PHX | Class II | 2025-07-03 |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. | JWH | Class II | 2025-07-02 |
| K250848 | Identity Shoulder System | Zimmer, Inc. | MBF | Class II | 2025-07-02 |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | MQV | Class II | 2025-07-02 |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | HSX | Class II | 2025-07-01 |
| K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | NKB | Class II | 2025-07-01 |
| K251933 | SnugFit ASA Extension | Medacta International S.A. | MBI | Class II | 2025-07-01 |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | 2025-06-30 |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | OVE | Class II | 2025-06-27 |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | MAX | Class II | 2025-06-27 |
| K242988 | Genostis Osteosynthesis System | Genostis AF | HRS | Class II | 2025-06-27 |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | TriMed, Inc. | HRS | Class II | 2025-06-26 |
| K251395 | The Rialto SI Fusion System | Medtronic Sofamor Danek USA, Inc. | OUR | Class II | 2025-06-26 |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | JWH | Class II | 2025-06-26 |
| K243275 | Equinoxe® Scapula Fracture System | Exactech, Inc. | HRS | Class II | 2025-06-26 |
| K251725 | ANAX OCT Spinal System | Cg Medtech Co., Ltd. | NKG | Class II | 2025-06-25 |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Smith & Nephew, Inc. | MBI | Class II | 2025-06-25 |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | PBF | Class II | 2025-06-25 |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | MAX | Class II | 2025-06-25 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | OVD | Class II | 2025-06-24 |
| K251362 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | HTY | Class II | 2025-06-24 |
| K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | HSN | Class II | 2025-06-20 |
| K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | NKB | Class II | 2025-06-18 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | OVD | Class II | 2025-06-18 |
| K251530 | CONMED Argo Knotless® Anchor | Conmed Corporation | MBI | Class II | 2025-06-18 |
| K251296 | The Acumed Wrist Fixation System | Acumed, LLC | HRS | Class II | 2025-06-18 |
| DEN240038 | Oxiplex® | Fziomed, Inc. | QVL | Class II | 2025-06-17 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | MAX | Class II | 2025-06-16 |
| K251166 | Mfinity Femoral System | Medacta International S.A. | MEH | Class II | 2025-06-13 |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | HWC | Class II | 2025-06-13 |
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | Medtronic Sofamor Danek, Inc. | MQV | Class II | 2025-06-12 |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | MAX | Class II | 2025-06-12 |
| K250559 | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | HSB | Class II | 2025-06-12 |
| K251459 | OneLIF Interbody Fusion System | Novapproach Spine, LLC | OVD | Class II | 2025-06-12 |
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | JDS | Class II | 2025-06-12 |
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments | Ht Medical D.B.A. Xenix Medical | NKB | Class II | 2025-06-12 |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | KWL | Class II | 2025-06-12 |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG | HRS | Class II | 2025-06-11 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | HTY | Class II | 2025-06-11 |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC | OUR | Class II | 2025-06-06 |
| K251131 | Annex® 2 Adjacent Level System | Spine Wave, Inc. | NKB | Class II | 2025-06-06 |
| K243456 | ONVOY Acetabular System | Globus Medical, Inc. | LPH | Class II | 2025-06-06 |
| K242431 | Omnia Medical PsiF DNA System | Omnia Medical, LLC | OUR | Class II | 2025-06-06 |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | LPH | Class II | 2025-06-05 |
| K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. | HRS | Class II | 2025-06-04 |
| K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | OUR | Class II | 2025-06-03 |
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop | Science & Bio Materials (S.B.M.) Sas | MBI | Class II | 2025-06-02 |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | MAX | Class II | 2025-06-02 |
| K250637 | VCFix Spinal System | Amber Implants | NDN | Class II | 2025-05-30 |
| K242751 | ARIX Pectus Bar System | Jeil Medical Corporation | HRS | Class II | 2025-05-30 |
| K243469 | SIGNEX | Osteonic Co., Ltd. | HRS | Class II | 2025-05-29 |
| K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | MQV | Class II | 2025-05-28 |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | MAI | Class II | 2025-05-27 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | LZO | Class II | 2025-05-23 |
17,115 clearances in the Orthopedic panel. Data: openFDA.