Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2026-10-02
Clearances · page 1 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K263086 | AltiVate Reverse® Glenosphere with RAVN Technology | Encore Medical L.P. | PHX | Class II | 2026-10-02 |
| K261607 | Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System | Spinal Simplicity, LLC | PEK | Class II | 2026-10-02 |
| K263113 | ZSAlign Cervical Interbody System | ZSFab, Inc. | OVE | Class II | 2026-10-02 |
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | HRS | Class II | 2026-10-02 |
| K263083 | Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | KTT | Class II | 2026-10-02 |
| K261217 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | NKB | Class II | 2026-10-02 |
| K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | HWC | Class II | 2026-10-02 |
| K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | LZO | Class II | 2026-10-01 |
| K263062 | NOVIX Pedicle Screw System | Tdm Co., Ltd. | NKB | Class II | 2026-10-01 |
| K263172 | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | NKB | Class II | 2026-09-30 |
| K262712 | Duet Spinal Fixation System | Duet Spine Holdings, LLC | NKB | Class II | 2026-09-30 |
| K262726 | NeckTune SA Cervical Cage | Medyssey Co., Ltd. | OVE | Class II | 2026-09-29 |
| K262721 | Spinalogic Bone Growth Stimulator | Djo, LLC | LOF | Class II | 2026-09-29 |
| K262649 | Alians Forearm | Newclip Technics | HRS | Class II | 2026-09-28 |
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | NKB | Class II | 2026-09-27 |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | HWC | Class II | 2026-09-25 |
| K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | PKC | Class II | 2026-09-24 |
| K262149 | corra® cervical plating system | Carlsmed, Inc. | KWQ | Class II | 2026-09-24 |
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | HSB | Class II | 2026-09-24 |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | HWC | Class II | 2026-09-23 |
| K263049 | SABER-C System | Elevation Spine | OVE | Class II | 2026-09-23 |
| K262067 | iFuse Granite Onyx Implant System | SI-BONE, Inc. | NKB | Class II | 2026-09-23 |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | HRS | Class II | 2026-09-23 |
| K261453 | G7® Acetabular System | Zimmer Biomet | LPH | Class II | 2026-09-23 |
| K254280 | F.A.S.T Screw | Steps Ortho | HWC | Class II | 2026-09-21 |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | HRS | Class II | 2026-09-18 |
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | NKB | Class II | 2026-09-17 |
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | MBI | Class II | 2026-09-17 |
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | MBH | Class II | 2026-09-17 |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | LZO | Class II | 2026-09-17 |
| K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | NKG | Class II | 2026-09-17 |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | HRS | Class II | 2026-09-15 |
| K262057 | GMK Extension | Medacta International SA | JWH | Class II | 2026-09-15 |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | NKB | Class II | 2026-09-14 |
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | OVD | Class II | 2026-09-11 |
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | JWH | Class II | 2026-09-11 |
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETE | Bone Solutions, Inc. | MQV | Class II | 2026-09-11 |
| K262293 | EVOLUTION MPX Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | JWH | Class II | 2026-09-10 |
| K262173 | N22 Offset Humeral Head | Shoulder Innovations, Inc. | KWT | Class II | 2026-09-08 |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | MBH | Class II | 2026-09-08 |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | JWH | Class II | 2026-09-08 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2026-09-04 |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | JWH | Class II | 2026-09-04 |
| K261057 | ActivaScrew Cannulated COM | Bioretec, Ltd. | HWC | Class II | 2026-09-04 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | HRS | Class II | 2026-09-03 |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | MBI | Class II | 2026-09-02 |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | LZO | Class II | 2026-09-02 |
| K253065 | Aevumed SUPERCYNCH Button System | Aevumed, Inc. | MBI | Class II | 2026-09-02 |
| K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | JDR | Class II | 2026-09-01 |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | JWH | Class II | 2026-09-01 |
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | HTY | Class II | 2026-08-28 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | HRS | Class II | 2026-08-28 |
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | HRX | Class II | 2026-08-28 |
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | LPH | Class II | 2026-08-28 |
| K262677 | Iconix Knotless T | Riverpoint Medical | MBI | Class II | 2026-08-27 |
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | ODP | Class II | 2026-08-26 |
| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | HRX | Class II | 2026-08-26 |
| K261381 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2026-08-24 |
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | JDI | Class II | 2026-08-24 |
| K260106 | OsteoCoil GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | HWC | Class II | 2026-08-24 |
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | OVE | Class II | 2026-08-21 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | MBH | Class II | 2026-08-21 |
| DEN250067 | ReneuRx (Neural Ice) | Brixton Biosciences | SJA | Class II | 2026-08-21 |
| K261049 | SCALA® TL | Spineart SA | MAX | Class II | 2026-08-20 |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2026-08-19 |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | ODP | Class II | 2026-08-18 |
| K262639 | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | QLQ | Class II | 2026-08-14 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | HRS | Class II | 2026-08-13 |
| K262344 | Large Compression Screws | TriMed, Inc. | HWC | Class II | 2026-08-12 |
| K261576 | Icona Hip Stem | Corin, Ltd. | MEH | Class II | 2026-08-10 |
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | MAI | Class II | 2026-08-07 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | JWH | Class II | 2026-08-07 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | KRO | Class II | 2026-08-06 |
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | JDR | Class II | 2026-08-06 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | HWC | Class II | 2026-08-05 |
| K254043 | TRIVANCE Hip Stem | Globus Medical, Inc. | LPH | Class II | 2026-08-04 |
| K261609 | Freedom Partial Knee System | Maxx Orthopedics, Inc. | HSX | Class II | 2026-08-04 |
| K261408 | SABER-XA System | Elevation Spine | OVD | Class II | 2026-08-03 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | MBI | Class II | 2026-08-03 |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | JWH | Class II | 2026-07-31 |
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | OVE | Class II | 2026-07-31 |
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | MQP | Class II | 2026-07-31 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | OVD | Class II | 2026-07-31 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | MBI | Class II | 2026-07-30 |
| K260624 | Arthrex Radial Head Replacement System | Arthrex, Inc. | KWI | Class II | 2026-07-30 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | MBI | Class II | 2026-07-29 |
| K261430 | TruLift Expandable System | Life Spine, Inc. | MAX | Class II | 2026-07-28 |
| K261511 | Xpert Ankle | Newclip Technics | HRS | Class II | 2026-07-28 |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | NKB | Class II | 2026-07-24 |
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | KWL | Class II | 2026-07-24 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | NKB | Class II | 2026-07-24 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | JWH | Class II | 2026-07-23 |
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | ODP | Class II | 2026-07-23 |
| K262094 | E3D-C Interbody System | Evolution Spine | OVE | Class II | 2026-07-22 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | HWC | Class II | 2026-07-22 |
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | KWS | Class II | 2026-07-22 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2026-07-21 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | MBI | Class II | 2026-07-20 |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2026-07-17 |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | ODP | Class II | 2026-07-17 |
17,115 clearances in the Orthopedic panel. Data: openFDA.