| Reselute Tibial Nail (K253517) | Reselute, Inc. | 2026-03-10 |
| DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (K254093) | Synthes GmbH | 2026-03-10 |
| Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189) | Zimmer, Inc. | 2026-03-09 |
| FiberTape Button (K260405) | Arthrex, Inc. | 2026-03-09 |
| DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069) | Synthes GmbH | 2026-03-09 |
| Treace Medical Concepts (TMC) Screw Fixation System (K260361) | Treace Medical Concepts, Inc. | 2026-03-06 |
| TeKBrace Knotless Anchor (K253538) | Theramicro | 2026-03-06 |
| Phantom® Hindfoot TTC/TC Nail System (K253591) | Paragon 28, Inc. | 2026-03-05 |
| Arthrex FibuLock Nail System (K252196) | Arthrex, Inc. | 2026-03-05 |
| ANTERIS Thoracolumbar Plate System (K260015) | SpineCraft | 2026-03-04 |
| Active Intramedullary (AIM) Tibial Nail System (K252025) | Satori Orthopaedics, Inc. | 2026-03-04 |
| Aevumed FENIX Suture Anchor (K254306) | Aevumed, Inc. | 2026-03-04 |
| PathLoc Lumbar Plate System (K251940) | L&K BIOMED Co., Ltd. | 2026-03-03 |
| Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (K260353) | Arthrex, Inc. | 2026-03-03 |
| Arthrex Nano FiberTak Suture Anchor (K254229) | Arthrex, Inc. | 2026-03-02 |
| VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (K254054) | Synthes GmbH | 2026-03-02 |
| LigaMend (K253695) | Riverpoint Medical, LLC | 2026-02-27 |
| HKT Anatomical Locking Trauma System (K254249) | Hankil Tech Medical Co., Ltd. | 2026-02-27 |
| SWINGO-3D Lumbar Cage System (K254017) | Implanet | 2026-02-26 |
| RIB LINK™ Fixation System (K252166) | Globus Medical, Inc. | 2026-02-26 |
| ENOS Software Guided External Fixation System (K253764) | Disior, Ltd. | 2026-02-26 |
| GMK 3D Metal Tibial Tray Extension (K253328) | Medacta International S.A. | 2026-02-26 |
| Aster (K254182) | Osteonic Co., Ltd. | 2026-02-26 |
| FIREFLY® Pedicle Screw Navigation Guide (K253472) | Mighty Oak Medical | 2026-02-25 |
| Ventana™ A Anterior Lumbar Interbody System (K253559) | Spinal Elements, Inc. | 2026-02-25 |
| OSSIOfiber® Suture Anchor (K254055) | OSSIO , Ltd. | 2026-02-24 |
| OSTEOMNI SPINAL FIXATION SYSTEM (K254247) | Osteomni, Inc. | 2026-02-24 |
| Duet™ Spinal Fixation System (K253169) | Box Spine, LLC | 2026-02-23 |
| LUX Expandable Lumbar Interbody System (K253583) | Xenix Medical | 2026-02-23 |
| KLS Martin Pure Pectus System (K253660) | KLS-Martin L.P. | 2026-02-20 |
| KLS Martin Ixos System (K254162) | KLS Martin L.P. | 2026-02-20 |
| ATLAS™ Expandable Osteotomy Wedge System (K252733) | MiRus, LLC | 2026-02-19 |
| Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (K253637) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| Biosteon® Screw (K251680) | Biocomposites, Ltd. | 2026-02-17 |
| Adaptos®Fuse Bone Graft (K253524) | Biomendex OY | 2026-02-17 |
| Hive™ Standalone Cervical System and Hive™ C Interbody System (K254105) | NanoHive Medical, LLC | 2026-02-13 |
| Wrist Fracture System (K251732) | Met One Technologies, LLC | 2026-02-12 |
| Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201) | 4Web, Inc. | 2026-02-12 |
| iFuse INTRA Ti™ Implant System (K253488) | SI-BONE, Inc. | 2026-02-11 |
| Vulcan Spinal System (K253545) | K2m, Inc. | 2026-02-10 |
| XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (K260073) | Biodynamik, Inc. | 2026-02-10 |
| Luna® Ti Interbody Fusion System (K250773) | Spinal Elements, Inc. | 2026-02-04 |
| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |
| E3D™-C Interbody System (K260038) | Evolution Spine | 2026-02-04 |
| Signature™ ONE System (K260104) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 |
| T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (K253640) | Stryker GmbH | 2026-02-03 |
| MSS - Monobloc stem (K250644) | Medacta International S.A. | 2026-02-03 |
| Falco Fusion System (K253611) | Mcnicoll Surgical, Inc. | 2026-01-29 |
| Y-Knotless™ Flex Anchors (K253763) | Conmed Corporation | 2026-01-29 |
| Mpact 3D Metal Implants Extension – DMLS Technology (K251043) | Medacta International S.A. | 2026-01-28 |
| Sacroiliac Joint Truss System (SJTS) (K252834) | 4Web Medical | 2026-01-28 |
| Aevumed PROTEKT Suture Anchor (K260004) | Aevumed, Inc. | 2026-01-28 |
| XeliteMed SuperM-Fix Spinal Bone Cement (K251896) | Xelite Biomed , Ltd. | 2026-01-28 |
| Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (K253748) | Life Spine, Inc. | 2026-01-23 |
| SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (K252352) | Lima Corporate S.P.A. | 2026-01-22 |
| OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252885) | Astura Medical | 2026-01-22 |
| Arthrex Variable Angle (VA) Proximal Tibia Plating System (K253713) | Arthrex, Inc. | 2026-01-21 |
| Infinity™ OCT System (K254165) | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 |
| Excelsior System (K253291) | Blue Ocean Global | 2026-01-20 |
| Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (K252205) | Curiteva, Inc. | 2026-01-16 |
| AltiVate Reverse® ADLC Glenosphere (K252567) | Encore Medical L.P. | 2026-01-15 |
| N22 EZ Glenosphere (K252516) | Shoulder Innovations, Inc. | 2026-01-15 |
| Curiteva Porous PEEK Cervical Interbody Fusion System (K254061) | Curiteva, Inc. | 2026-01-15 |
| TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) (K254002) | TriMed, Inc. | 2026-01-15 |
| SDS Growing Rod (K251961) | BAAT Medical Products B.V. | 2026-01-15 |
| Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171) | Maxx Orthopedics, Inc. | 2026-01-15 |
| Cervical Interbody and VBR Fusion System (K252219) | Sync Surgical | 2026-01-14 |
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K251214) | Miach Orthopaedics, Inc. | 2026-01-13 |
| Swedge™ Pedicle Screw Fixation System Bezier Rod (K252461) | Spinal Resources, Inc. | 2026-01-13 |
| Precision AI Surgical Planning System (PAI-SPS) (K251558) | Precision AI Pty, Ltd. | 2026-01-12 |
| Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (K252807) | Arthrex, Inc. | 2026-01-12 |
| JARVIS Metaphyseal Stem (K254003) | FH Industrie | 2026-01-09 |
| Advantage-C™ Ti3D Cervical Interbody Fusion Device (K252711) | Intelivation Technologies | 2026-01-08 |
| Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (K252788) | Tornier, Inc. | 2026-01-08 |
| Titanium Interbody System (K253266) | Spine Innovation, LLC | 2026-01-08 |
| CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (K253941) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| VyBrate™ VBR System (K253158) | Vy Spine, LLC | 2026-01-07 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253990) | S.M.A.I.O | 2026-01-07 |
| Materialise TKA Guide System (K253793) | Materialise NV | 2026-01-06 |
| QuadLock™ Fixation System (K253618) | Abanza Tecnomed S.L | 2026-01-06 |
| aprevo® cervical interbody system (K252894) | Carlsmed, Inc. | 2026-01-06 |
| TRILEAP Plating System (K253178) | Crossroads Extremity Systems | 2026-01-06 |
| Tyber Medical Trauma Screw (K252901) | Tyber Medical, LLC | 2025-12-31 |
| Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (K253895) | Arthrex, Inc. | 2025-12-30 |
| ZipToe™ Hammertoe Fusion System (K253325) | Toetal Solutions | 2025-12-29 |
| OsteoRemedies Hip Spacer System (K253675) | Osteoremedies, LLC | 2025-12-23 |
| Active-V Total Knee System; World Total Knee System (K253239) | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (K253217) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 |
| HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876) | Globus Medical, Inc. | 2025-12-22 |
| aprevo® cervical plating system (K252611) | Carlsmed, Inc. | 2025-12-22 |
| Syndesmosis TightRope PRO (K253727) | Arthrex, Inc. | 2025-12-22 |
| MSFX MIKRON PEEK CAGES (K252781) | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 |
| Hoffmann LRF System (K253202) | Stryker GmbH | 2025-12-19 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |
| Pectus Versa System (K251050) | Gm Dos Reis Industria E Comercio | 2025-12-19 |
| IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (K253577) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| Balanced Knee System TriMax Porous Femoral Components (K253161) | Ortho Development Corp. | 2025-12-19 |
| EMPOWR Knee (K252974) | Encore Medical L.P. | 2025-12-19 |
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (K252191) | Bonebridge AG | 2025-12-17 |