| Tesera-k PL System and Tesera-k XL System (K242771) | Kyocera Medical Technologies, Inc. | 2025-03-20 |
| TriMed Ankle Fixation System (K243999) | TriMed, Inc. | 2025-03-19 |
| Tyber Medical Anatomical Plating System (K242486) | Tyber Medical, LLC | 2025-03-19 |
| TriMed Elbow and Forearm System (K243987) | TriMed, Inc. | 2025-03-19 |
| FortiVy™ OsteoVy™ Lumbar IBF (K241783) | Vy Spine, LLC | 2025-03-18 |
| The OsteoCentric Bone Plate and Screw System (K250494) | OsteoCentric Technologies | 2025-03-18 |
| BPS Wrist Fracture System (K250498) | Orthonovis, Inc. | 2025-03-17 |
| aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (K243802) | Carlsmed, Inc. | 2025-03-17 |
| Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (K250526) | Arthrex, Inc. | 2025-03-14 |
| VerteGlide Spinal Growth Guidance System (K241816) | OrthoPediatrics Corp. | 2025-03-14 |
| NEXXT MATRIXX® SI System (K243838) | Nexxt Spine | 2025-03-14 |
| MedCAD® AccuStride™ System (K241811) | Medcad | 2025-03-13 |
| Freedom Total Knee System (All-poly Tibial Plate) (K250382) | Maxx Orthopedics, Inc. | 2025-03-13 |
| EVOL® ha – Hyper C Cervical Interbody Fusion System (K250605) | Cutting Edge Spine, LLC | 2025-03-12 |
| Arthrex TightRope Soft Button, RT (K250424) | Arthrex, Inc. | 2025-03-11 |
| Origin™ TT Stem (K243029) | Signature Orthopaedics Pty, Ltd. | 2025-03-11 |
| AGILON® XO Shoulder Replacement System (K241944) | Implantcast GmbH | 2025-03-10 |
| Alteon® HA Femoral Stems (K243839) | Exactech, Inc. | 2025-03-10 |
| Orthex External Fixation System (K243798) | OrthoPediatrics Corp. | 2025-03-07 |
| APTUS Hand System; APTUS Elbow Dorsal Olecranon (K243610) | Medartis AG | 2025-03-07 |
| Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (K243724) | Zimmer, Inc. | 2025-03-06 |
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K243578) | Miach Orthopaedics, Inc. | 2025-03-06 |
| Versacem Acetabular Shell and Double Mobility HC Liners (K241767) | Medacta International S.A. | 2025-03-06 |
| TITANEX Screw Systems (K250304) | Vilex, LLC | 2025-03-05 |
| Biolox® Delta Revision heads (K243809) | Limacorporate | 2025-03-04 |
| MedalOne Total Knee System (K244039) | Suzhou Microport Orthorecon Co., Ltd. | 2025-02-28 |
| DYNAMIS™ SI Screw System (K243565) | Promethean Restorative, LLC | 2025-02-28 |
| VADER® Pedicle System and VADER®one Pedicle System (K242900) | Icotec AG | 2025-02-27 |
| CastleLoc Pectus Bar System (K243357) | L&K BIOMED Co., Ltd. | 2025-02-27 |
| BonVie+ (K250346) | Elute, Inc. | 2025-02-26 |
| WasherCap™ Fixation System (K250238) | Abanza Tecnomed S.L | 2025-02-25 |
| Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (K241555) | Rti Surgical, Inc. | 2025-02-21 |
| Primus Spinal Fixation System (K243916) | Spinal Elements, Inc. | 2025-02-21 |
| Fassier-Duval Telescoping IM System (K241983) | Orthopediatrics Canada Ulc Dba Pega Medical | 2025-02-21 |
| Extremity Medical External Fixation System (K241563) | Extremity Medical, LLC | 2025-02-21 |
| CORE Shoulder System (K241470) | LinkBio Corp. | 2025-02-20 |
| Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (K243344) | Arthrex, Inc. | 2025-02-20 |
| SuperBall-RC™ (K244015) | Arcuro Medical , Ltd. | 2025-02-19 |
| A.L.P.S. Small Fragment Plating System (K243761) | Biomet Orthopedics | 2025-02-19 |
| EVOS Pelvic and Acetabular System (K241666) | Smith & Nephew | 2025-02-19 |
| FIX-C 3D Ti ACIF System (K243915) | Jeil Medical Corporation | 2025-02-18 |
| Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (K243574) | Microport Orthopedics, Inc. | 2025-02-18 |
| Newclip Patient-matched instrumentation non sterile PSI (K243912) | Newclip Technics | 2025-02-13 |
| Freedom® Total Knee System - Porous Tibial Base Plate (K241597) | Maxx Orthopedics, Inc. | 2025-02-13 |
| Affixus Tibial Nailing System - 4mm screws (K243907) | Zimmer, Inc. | 2025-02-12 |
| CYLOX® ST (K243188) | Signus Medizintechnik GmbH | 2025-02-11 |
| InSet Total Shoulder System (K241817) | Shoulder Innovations, Inc. | 2025-02-11 |
| Locking Plates and Screws Systems (K240958) | Hebei Ruihe Medical Devices Co., Ltd. | 2025-02-10 |
| Genesys Spine AIS-C II Cervical Interbody Fusion System (K242483) | Genesys Spine | 2025-02-07 |
| ceramys™ femoral head system (K241483) | Encore Medical L.P. | 2025-02-07 |
| Signature Osteosynthesis Plate System (K241599) | Signature Orthopaedic Pty , Ltd. | 2025-02-06 |
| Stryker Orthopaedics Hip Devices Labeling Update (K243784) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert (K243817) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| BPS - Bone Fragment Fixation Plates, Screws and Washers (K250055) | Orthonovis, Inc. | 2025-02-06 |
| Caliber Intramedullary Fixation System (K242896) | Nvision Biomedical Technologies | 2025-02-05 |
| GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (K243790) | Depuy Mitek | 2025-02-05 |
| Tiger 2 System (K243908) | Zavation Medical Products, LLC | 2025-02-03 |
| IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (K241375) | Alphatec Spine | 2025-02-03 |
| Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K242442) | Innovate Orthopaedics, Ltd. | 2025-01-31 |
| Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (K243665) | ZheJiang Decans Medical Devices Co., Ltd. | 2025-01-31 |
| Arthrex DynaNite Nitinol Staples (K243742) | Arthrex, Inc. | 2025-01-31 |
| MyShoulder Planner (5.3SSWPL) (K241292) | Medacta International S.A. | 2025-01-30 |
| Osprey Suture Anchor (K243726) | Responsive Arthroscopy, Inc. | 2025-01-30 |
| WasherCap™ Mini Fixation System (Model 45) (K243712) | Abanza Tecnomed S.L | 2025-01-30 |
| Xenco Medical CancelleX Cervical Interbody System (K243673) | Xenco Medical, LLC | 2025-01-29 |
| Versalock Upper Limb Plating System (K243740) | GM Dos Reis Industria e Comercio Ltda. | 2025-01-29 |
| Argo Knotless GENESYS Anchor (K244025) | Conmed Corporation | 2025-01-28 |
| AxCess® Expandable Interbody System (K243739) | Elliquence, LLC | 2025-01-24 |
| Acu-Sinch Knotless Mini (K243624) | Acumed, LLC | 2025-01-23 |
| OTS 25-L (100-5) (K241234) | Ots Medical , Ltd. | 2025-01-23 |
| ProLift Pivot Expandable Spacer System (K243668) | Life Spine, Inc. | 2025-01-23 |
| XT3 System (K241357) | Biodynamik, Inc. | 2025-01-22 |
| EMPHASYS Acetabular System (K243977) | Depuy Ireland UC | 2025-01-22 |
| Precision AI Surgical Planning System (PAI-SPS) (K243955) | Precision AI Pty, Ltd. | 2025-01-21 |
| Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706) | Medtronic Sofamor Danek, Inc. | 2025-01-17 |
| TriALTIS™ Spine System (K243249) | Medos International SARL | 2025-01-17 |
| TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); (K243569) | TriMed, Inc. | 2025-01-15 |
| EffortMed Spinal Fixation System (K243946) | Effortmed, LLC | 2025-01-15 |
| Consensus Knee System with TiNbN (K241180) | Shalby Advanced Technologies | 2025-01-14 |
| Elegance® Anterior Cervical plate (K243904) | Clariance | 2025-01-14 |
| Pantheon Proximal Femur Reconstruction (PFR) System (K241059) | Adler Ortho S.P.A | 2025-01-13 |
| Initia Knee System (K243295) | Kyocera Medical Technologies, Inc. | 2025-01-13 |
| Arthrex Intramedullary Nails (K243890) | Arthrex, Inc. | 2025-01-13 |
| Universal Tendon Spacer (K243477) | Askorn Medical | 2025-01-10 |
| Arthrex SS VAL and VAL KreuLock™ Compression Screw System (K243195) | Arthrex, Inc. | 2025-01-10 |
| MASADA Modular Spinal Fixation System (K243259) | Astura Medical | 2025-01-07 |
| Conformity Stem Extension Line, #0 (K243466) | United Orthopedic Corporation | 2025-01-06 |
| Idys® LIF (K243670) | Clariance | 2024-12-31 |
| TiLink-P SI Joint Fusion System (K243835) | SurGenTec, LLC | 2024-12-27 |
| TMC Compression Implant System (K243658) | Treace Medical Concepts | 2024-12-26 |
| ARTFX Trauma Bone Plate and Screw System (K242939) | Artfx Medical | 2024-12-23 |
| GlassBone Granules (K242782) | Noraker | 2024-12-23 |
| INHANCE INTACT™ (K243248) | Depuy Ireland UC | 2024-12-23 |
| NEO Pedicle Screw System™ (K243693) | Neo Medical SA | 2024-12-23 |
| OsteoFlo HydroFiber (K242797) | SurGenTec, LLC | 2024-12-23 |
| Bolo Button System (K242091) | Fusion Orthopedics | 2024-12-23 |
| Cellbrick Knee Spacer (K243024) | United Orthopedic Corporation | 2024-12-20 |
| BioSphere Putty; BioSphere MIS Putty (K241167) | Synergy Biomedical | 2024-12-20 |
| Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (K243308) | Bonebridge AG | 2024-12-20 |
| Zimmer® Persona® Personalized Knee System (K243293) | Zimmer Biomet | 2024-12-20 |