| BluEX Cervical Expandable Cage System (K260840) | L&K BIOMED Co., Ltd. | 2026-05-16 |
| Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (K260536) | Depuy Ireland UC | 2026-05-15 |
| Varion Thoracolumbar Fixation System (K260989) | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| Ventana® P/T Lumbar Interbody System (K260506) | Spinal Elements, Inc. | 2026-05-15 |
| ARIES Anterior Cervical Plate Systems (K252776) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
| TriMed Compression Screws (K261241) | TriMed, Inc. | 2026-05-14 |
| Y-Knotless™ Flex Anchors (K261363) | CONMED Corporation | 2026-05-13 |
| VersaLift Expandable System (K260837) | Life Spine, Inc. | 2026-05-12 |
| OSTEOMNI SPINAL CAGES SYSTEM (K260850) | Osteomni, Inc. | 2026-05-12 |
| aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (K260385) | Carlsmed, Inc. | 2026-05-09 |
| Avanti Distal Elbow ORIF System (K261145) | Avanti Orthopaedics, LLC | 2026-05-09 |
| Arthrex Beaming System (K254215) | Arthrex, Inc. | 2026-05-08 |
| Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991) | Orthofix Srl | 2026-05-08 |
| SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739) | Globus Medical, Inc. | 2026-05-07 |
| Veritas Reverse Total Shoulder System (K253992) | Restor3D | 2026-05-07 |
| Anchor with Fiber Wire and Disposable Inserter (K253027) | Ortobio S.A. | 2026-05-06 |
| CastleLoc-P Anterior Cervical Plate System (K261112) | L&K BIOMED Co., Ltd. | 2026-05-06 |
| MectaLIF 3D Metal Anterior (K254202) | Medacta International S.A. | 2026-05-05 |
| AccelFix Spinal Fixation System (K261130) | L&K BIOMED Co., Ltd. | 2026-05-05 |
| ArthroTAK Tendon Anchor Kit (K252635) | ArthroTAK, LLC | 2026-05-01 |
| FX V135 EASYTECH® Shoulder System (K254154) | FX Shoulder Solutions, Inc. | 2026-05-01 |
| OSSIOfiber® Threaded Trimmable Fixation Nail (K254077) | OSSIO , Ltd. | 2026-05-01 |
| Oxiplex (K253326) | Fziomed, Inc. | 2026-05-01 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System (K253966) | Spineart SA | 2026-05-01 |
| BEE PLIF Cage (K261067) | NGMedical GmbH | 2026-04-30 |
| OrthoPediatrics® Locking Cannulated Blade Plate System (K260323) | OrthoPediatrics Corp. | 2026-04-30 |
| SCRIPT™ Implant System (K253401) | Globus Medical, Inc. | 2026-04-29 |
| LEO Spinal System (K252542) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| M.U.S.T. Pedicle Screw System - Extension (K253940) | Medacta International S.A. | 2026-04-28 |
| Avenir® Müller Stem; Avenir Complete™ Hip System (K260182) | Zimmer, Inc. | 2026-04-27 |
| SABER-C System (K260660) | Elevation Spine | 2026-04-27 |
| NovoKnee (SteriKnee) (K261032) | NovoSource | 2026-04-27 |
| PC Fix System (K260411) | Chest Wall Innovations, Inc. | 2026-04-24 |
| ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (K260549) | Zsfab, Inc. | 2026-04-24 |
| I.T.S. PRS Phoenix II (K260054) | I.T.S. GmbH | 2026-04-24 |
| AUTOBAHN™ Nailing System (K261043) | Globus Medical, Inc. | 2026-04-24 |
| EPORE® XO cup system (K252451) | Implantcast GmbH | 2026-04-24 |
| Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute (K261008) | Stryker Spine | 2026-04-24 |
| POYA 3.5mm Medial Proximal Tibia System (K260228) | Bonebridge AG | 2026-04-24 |
| corra™ cervical plating system (K260570) | Carlsmed, Inc. | 2026-04-22 |
| Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (K260921) | Tigon Medical | 2026-04-21 |
| CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (K260216) | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| SAGI Cervical Cage System (K253213) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| DYNEX® External Fixation Systems (K260900) | Vilex, LLC | 2026-04-17 |
| TITAN Nail; APTUS K-Wire System (K260934) | Medartis AG | 2026-04-17 |
| ORIO-3D Cage System (K253260) | SpineCraft | 2026-04-16 |
| Freedom DS™ Decompression System (K253523) | Spinal Simplicity | 2026-04-16 |
| ARx® SAI Implant System (K254274) | Life Spine, Inc. | 2026-04-16 |
| Uni-C Cervical Cage System (K252774) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (K252404) | Biomet Orthopedics | 2026-04-15 |
| Refobacin Bone Cement R (110034355) (K254107) | Biomet France | 2026-04-15 |
| Equinoxe® Shoulder System (K260583) | Exactech, Inc. | 2026-04-14 |
| HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (K260340) | HC Biologics, LLC | 2026-04-13 |
| b-ONE® Bipolar Head (K253357) | B-One Ortho, Corp. | 2026-04-13 |
| Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592) | Zimmer, Inc. | 2026-04-13 |
| InSet Reverse Total Shoulder System (K254128) | Shoulder Innovations, Inc. | 2026-04-13 |
| SMART Osteotomy System (K260090) | Actis Medical Pty., Ltd. | 2026-04-10 |
| CoAptix S System (K252699) | University of Utah, Department of Orthopaedics | 2026-04-10 |
| CATAMARAN™ SI Joint Fusion System (K260477) | Tenon Medical | 2026-04-08 |
| AETOS Shoulder System - CONCELOC Glenoids (K254084) | Smith & Nephew, Inc. | 2026-04-06 |
| Tyber Medical Trauma Screw (K253042) | Tyber Medical, LLC | 2026-04-03 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K260786) | S.M.A.I.O | 2026-04-03 |
| HYALEX® MTP Hemiarthroplasty Implant (K250074) | Hyalex Orthopaedics, Inc. | 2026-04-03 |
| Blueprint Patient-Specific Instrumentation (K253674) | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 |
| Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| enHAnce PEEK Bunion System (K253718) | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| MOD-C (K242303) | Orthomod, LLC | 2026-04-01 |
| implantcast Packaging System Update (K260037) | Implantcast GmbH | 2026-03-30 |
| Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (K252240) | Spectrum Spine | 2026-03-30 |
| Synergy Disc Instruments (K253392) | Synergy Spine Solutions, Inc. | 2026-03-27 |
| MedCAD® AccuStride™ System (K252064) | Medcad | 2026-03-27 |
| VyPlate™ Anterior Cervical Plate System (K260697) | Vy Spine, LLC | 2026-03-27 |
| SF Push-in Anchor (K260294) | Surgical Fusion Technologies GmbH | 2026-03-27 |
| SportLinc Syndesmosis Device (K252081) | Lincotek Medical | 2026-03-27 |
| Flex-Z™ Cervical Cage (K252432) | Spinepoint, LLC | 2026-03-25 |
| Airlock® Ankle Plating System (K260274) | Novastep SAS | 2026-03-25 |
| Vortex5 Tailor's Bunion Correction System (K260291) | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| Invictus Bands System (K253615) | Alphatec Spine, Inc. | 2026-03-25 |
| LOQTEQ® VA Proximal Humerus Plate 3.5 (K254253) | Aap Implantate AG | 2026-03-24 |
| QuikFix External Fixator: Knee-Spanning Pack (K260112) | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| Clavicle Fixation System (K254288) | Skeletal Dynamics, Inc. | 2026-03-23 |
| Arthrex Humeral Nails (K252016) | Arthrex, Inc. | 2026-03-20 |
| Arthrex FiberTak Suture Anchor (K260561) | Arthrex, Inc. | 2026-03-20 |
| CastleLoc Pectus Bar System (K260448) | L&K BIOMED Co., Ltd. | 2026-03-19 |
| DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (K254110) | MedShape, Inc. | 2026-03-18 |
| Fusion FibFix Nail (K252961) | Fusion Orthopedics USA, LLC | 2026-03-18 |
| APS Spear Locking Plate (K254053) | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
| Grappler Suture Anchor PCFD Tether System (K253886) | Paragon 28, Inc. | 2026-03-17 |
| Super Upper Limbs Versalock Plating System (K260390) | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (K254045) | CarboFix Orthopedics , Ltd. | 2026-03-16 |
| APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (K253916) | Medartis AG | 2026-03-16 |
| SINEFIX (K254176) | BAAT Medical Products B.V. | 2026-03-16 |
| Trax EX Anchor (K251750) | Trax Surgical, Inc. | 2026-03-12 |
| Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (K252824) | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| implaFit® short stems (K252401) | Implantcast GmbH | 2026-03-12 |
| VantageTM Lumbar Decompression Kit (K252546) | Allevion Medical, LLC | 2026-03-12 |
| Affixus Retrograde Femoral Nailing System (K253566) | Zimmer, Inc. | 2026-03-12 |
| Xpert Hand (K253906) | Newclip Technics | 2026-03-11 |
| Strut Suture; No-Tie Button (K253693) | Riverpoint Medical, LLC | 2026-03-11 |
| INHANCE™ Reverse Shoulder System (K253624) | Depuy Ireland UC | 2026-03-11 |