| Kinos Total Ankle System (K242868) | Restor3D | 2024-10-18 |
| NOVA Minimally Invasive System (K242899) | Baui Biotech Co., Ltd. | 2024-10-17 |
| Vy Spine™ VyLam™ Laminoplasty System (K242784) | Vy Spine, LLC | 2024-10-16 |
| Legend® Acetabular Shell (K242833) | Ortho Development Corp. | 2024-10-11 |
| Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (K241491) | Stryker Corporation (Tornier, S.A.S.) | 2024-10-10 |
| GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (K230325) | Greens Surgicals Pvt. , Ltd. | 2024-10-10 |
| KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (K233947) | Ctl Medical Corporation | 2024-10-10 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K241477) | Carlsmed, Inc. | 2024-10-09 |
| OsteoCentric Technologies Cannulated Fasteners and Nuts (K242691) | OsteoCentric Technologies | 2024-10-09 |
| Clavicle and Scapula System (K240181) | Auxein Medical Pvt., Ltd. | 2024-10-09 |
| Gemini Medical Cage System (K242267) | ZheJiang Decans Medical Devices Co., Ltd. | 2024-10-08 |
| ProLift Wedge Expandable Spacer System (K242826) | Life Spine, Inc. | 2024-10-08 |
| EMPHASYS Acetabular Shell with RapiTite HA (K242084) | Depuy Ireland UC | 2024-10-07 |
| EARP Interbody System (K242457) | Retropsoas Technologies, LLC | 2024-10-07 |
| OvertureTi Knee Resurfacing SystemTM (K242746) | Overture Orthopaedics | 2024-10-07 |
| OR3O Dual Mobility System (K242375) | Smith & Nephew, Inc. | 2024-10-07 |
| Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (K242445) | Stryker GmbH | 2024-10-06 |
| BPS Wrist Fracture System (K242343) | Orthonovis, Inc. | 2024-10-04 |
| IdentiTi™ II Interbody System (K242364) | Alphatec Spine, Inc. | 2024-10-04 |
| Treace Medical Concepts (TMC) Screw Fixation System (K242671) | Treace Medical Concepts, Inc. | 2024-10-04 |
| Exactech® TRULIANT® Knee System (K240393) | Exactech, Inc. | 2024-10-03 |
| Icona Hip Stem (K241472) | Corin U.S.A. Limited | 2024-10-03 |
| Interwedge® Standalone Lateral (K241487) | Foundation Surgical Group, Inc. | 2024-10-02 |
| ARTFX Lumbar PEEK Cages (K240889) | Artfx Medical | 2024-10-02 |
| REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (K242377) | Osteoremedies, LLC | 2024-10-02 |
| Arthrex Virtual Implant Positioning (VIP) System Software (K241097) | Arthrex, Inc. | 2024-10-02 |
| MSFX MIKRON SPINAL FIXATION SYSTEM (K241657) | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-09-30 |
| Cannulated PsiFGuard (K241895) | Spineguard | 2024-09-26 |
| Protean Fragment Plating System (K241815) | Skeletal Dynamics, Inc. | 2024-09-26 |
| Affixus Tibial and Antegrade Femoral Nailing System (K241651) | Zimmer, Inc. | 2024-09-26 |
| Cove Putty, OsteoCove Putty (K242273) | SeaSpine Orthopedics Corporation | 2024-09-25 |
| NovaBone Putty - Synthetic Bioactive Bone Graft (K242299) | Novabone Products, LLC | 2024-09-25 |
| LumiVy™ Lumbar IBF System (K233807) | Vy Spine, LLC | 2024-09-24 |
| Unity Total Knee System (K241570) | Corin U.S.A. Limited | 2024-09-23 |
| aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (K241332) | Carlsmed, Inc. | 2024-09-20 |
| Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (K242147) | Alphatec Spine, Inc. | 2024-09-20 |
| TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061) | Smith & Nephew, Inc. | 2024-09-20 |
| Pectus Blu Support Bar System (K241709) | Biomet Microfixation | 2024-09-19 |
| HAnano InterFuse(R) Modular Interbody (K242509) | Next Orthosurgical | 2024-09-19 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775) | Xelite Biomed , Ltd. | 2024-09-18 |
| Response Ortho Metaphyseal Hinge Fixator System (K241769) | Response Ortho Solutions, LLC | 2024-09-18 |
| 3D Printed PEEK Interbody System (K240250) | Nvision Biomedical Technologies, Inc. | 2024-09-17 |
| TriMed Bridge Plates (K241942) | TriMed, Inc. | 2024-09-17 |
| TheRay Collared and Collarless Femoral Stem (K241875) | Nextstep Arthropedix | 2024-09-13 |
| EXULT Knee Replacement System (K242401) | Corentec Co., Ltd. | 2024-09-12 |
| Extremity All Suture System (K241695) | Field Orthopaedics | 2024-09-12 |
| Signus Tetris™ St; Signus Tetris™ R St (K241438) | Signus Medizintechnik GmbH | 2024-09-11 |
| Rx Knee System (K240683) | Signature Orthopaedics Pty, Ltd. | 2024-09-11 |
| HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (K241010) | Depuy Mitek | 2024-09-11 |
| Tornier Humeral Reconstruction System (Tornier HRS) (K241609) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| Pitkar Spinal Pedicle Screw System (K240233) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2024-09-09 |
| TriALTIS™ Spine System (K242042) | Medos International SARL | 2024-09-09 |
| ACS® LD FB Knee System (K234044) | Implantcast GmbH | 2024-09-06 |
| IB3D™ PL Spinal System (K241164) | Medicrea International S.A.S. (Medtronic) | 2024-09-06 |
| Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) (K232996) | Shanghai Iatrical-Ti Technologies CO , Ltd. | 2024-09-06 |
| TMC Compression Implant System (K242415) | Treace Medical Concepts | 2024-09-06 |
| COSINE™ Spacer (K234035) | Globus Medical, Inc. | 2024-09-06 |
| Fine Osteotomy™ (K241356) | Bodycad Laboratories, Inc. | 2024-09-05 |
| Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology (K241605) | Nanovis, LLC | 2024-09-05 |
| EVOS Patella Plates (K240487) | Smith & Nephew | 2024-09-03 |
| Eminent Spine Scoliosis Deformity Pedicle Screw System (K242069) | Eminent Spine | 2024-09-03 |
| Arthrex VAL and VAL KreuLock™ Compression Screw System (K241592) | Arthrex, Inc. | 2024-08-31 |
| Conformity Stem Extension Line (K242249) | United Orthopedic Corporation | 2024-08-30 |
| Salto Talaris Ankle PSI System (K241148) | 3D Systems, Inc. | 2024-08-30 |
| Cadence Ankle PSI System (K241326) | 3D Systems, Inc. | 2024-08-30 |
| Orthopeasia Spinal Fixation System (K240180) | Orthopeasia Co., Ltd. | 2024-08-30 |
| 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 Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips (K242280) | Stryker Spine | 2024-08-29 |
| VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (K242296) | Ortho-Design (Pty), Ltd. | 2024-08-29 |
| REDEMPTION Charcot Plating System (K233816) | Vilex, LLC | 2024-08-28 |
| OSSIOfiber® Compression Staple (K241932) | OSSIO , Ltd. | 2024-08-28 |
| Z1 Cemented Hip System (K241241) | Orchard Medical Development, LLC | 2024-08-27 |
| SITTER 3.5mm Versatile System (K240318) | Bonebridge AG | 2024-08-23 |
| Phantom Fibula Nail System (K234128) | Paragon 28, Inc. | 2024-08-22 |
| Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System (K230071) | Tdm Co., Ltd. | 2024-08-22 |
| TRIGEN INTERTAN 10S Nail System (K241804) | Smith & Nephew, Inc. | 2024-08-22 |
| TiLink-P SI Joint Fusion System (K242141) | SurGenTec, LLC | 2024-08-21 |
| Montage-XT Settable, Resorbable Bone Putty (K233566) | Orthocon, Inc. | 2024-08-21 |
| PYXIS 3D Titanium Cervical Cage system (K241738) | GS Medical Co., Ltd. | 2024-08-20 |
| iFuse TORQ TNT™ Implant System (K241504) | SI-BONE, Inc. | 2024-08-19 |
| RibFix Titan™ Fixation System (K241282) | Riverpoint Medical | 2024-08-19 |
| NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate (K241754) | Zimmer Switzerland Manufacturing GmbH | 2024-08-15 |
| SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K241813) | Si-Technology, LLC | 2024-08-13 |
| CoLink NeoFuse MIS Plating System (see attached parts list) (K241387) | In2bones USA | 2024-08-13 |
| aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) (K241328) | Carlsmed, Inc. | 2024-08-12 |
| E3D™-C Interbody System (K241846) | Evolution Spine | 2024-08-12 |
| Precision AI Surgical Planning System (PAI-SPS) (K233992) | Precision AI Pty, Ltd. | 2024-08-05 |
| Fixone Meniscal Repair (K233601) | Aju Pharm Co., Ltd. | 2024-08-02 |
| Cortera™ Spinal Fixation System (K241892) | Xtant Medical Holdings, Inc. | 2024-08-02 |
| Medline UNITE® MIS Foot Recon Screw System (K241359) | Medline Industries, LP | 2024-08-02 |
| Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (K241716) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (K241564) | Baxter Healthcare Corporation | 2024-08-02 |
| Logical Liner; World Liner; World Knee Patella (K241690) | Signature Orthopaedics Pty, Ltd. | 2024-08-01 |
| DePuy Synthes Retrograde Femoral Nail Advanced System (K233696) | DePuy Synthes | 2024-08-01 |
| EXULT Knee Replacement System (K242046) | Corentec Co., Ltd. | 2024-08-01 |
| Freefix Forearm Plating System (K242055) | Skeletal Dynamics, Inc. | 2024-08-01 |
| TACTIX Vector Syndesmosis System (K240035) | Vilex, LLC | 2024-08-01 |
| CarboClear® X Pedicle Screw System (K233793) | CarboFix Orthopedics , Ltd. | 2024-08-01 |
| Activmotion S (K241539) | Newclip Technics | 2024-07-30 |
| BIOCHARGE (K241912) | Nanofiber Solutions, LLC | 2024-07-29 |
| Solar™ Lumbar Interbody Fusion System (K240326) | Degen Medical, Inc. | 2024-07-29 |