| Curiteva Porous PEEK Standalone ALIF System (K250845) | Curiteva, Inc. | 2025-06-18 |
| Oxiplex® (DEN240038) | Fziomed, Inc. | 2025-06-17 |
| X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (K251617) | Expanding Innovations, Inc. | 2025-06-16 |
| Mfinity Femoral System (K251166) | Medacta International S.A. | 2025-06-13 |
| Eleganz Fusion Screw System (Fusion Screw System) (K250251) | Dev4 | 2025-06-13 |
| RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (K251154) | Ht Medical D.B.A. Xenix Medical | 2025-06-12 |
| OneLIF™ Interbody Fusion System (K251459) | Novapproach Spine, LLC | 2025-06-12 |
| GMReis Fibula Nail System (K250559) | Gm Dos Reis Industria E Comercio | 2025-06-12 |
| FIX-L PEEK PLIF and T-PLIF System (K243973) | Jeil Medical Corporation | 2025-06-12 |
| TRIGEN Stable Lock Nut & Washer (K243608) | Smith & Nephew, Inc. | 2025-06-12 |
| Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (K251193) | Medtronic Sofamor Danek, Inc. | 2025-06-12 |
| Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (K242865) | Biocomposites, Ltd. | 2025-06-12 |
| LORRAINE 2.5/3.5mm Distal Humerus System (K250933) | Bonebridge AG | 2025-06-11 |
| Impact PEEK Union Nail System (K250646) | Nvision Biomedical Technologies | 2025-06-11 |
| ONVOY™ Acetabular System (K243456) | Globus Medical, Inc. | 2025-06-06 |
| Omnia Medical PsiF DNA™ System (K242431) | Omnia Medical, LLC | 2025-06-06 |
| SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K251525) | Si-Technology, LLC | 2025-06-06 |
| Annex® 2 Adjacent Level System (K251131) | Spine Wave, Inc. | 2025-06-06 |
| Trinity EVO Acetabular Shell (K242744) | Corin U.S.A. Limited | 2025-06-05 |
| Montblanc Plate System (K243368) | Medifield Medical Co., Ltd. | 2025-06-04 |
| Patriot SI Implant System (K250001) | Spinal Simplicity, LLC | 2025-06-03 |
| Tera Lumbar Interbody Fusion System (Various PNs) (K251335) | Acuity Surgical Devices, LLC | 2025-06-02 |
| PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop (K250844) | Science & Bio Materials (S.B.M.) Sas | 2025-06-02 |
| VCFix Spinal System (K250637) | Amber Implants | 2025-05-30 |
| ARIX Pectus Bar System (K242751) | Jeil Medical Corporation | 2025-05-30 |
| SIGNEX (K243469) | Osteonic Co., Ltd. | 2025-05-29 |
| OsteoFlo HydroFiber (K243949) | SurGenTec, LLC | 2025-05-28 |
| OSSIOfiber® Suture Anchor (K251309) | OSSIO , Ltd. | 2025-05-27 |
| MagnetOs MIS (K243474) | Kuros Biosciences B.V | 2025-05-23 |
| RECLAIM Monobloc Revision Femoral Stem (K251292) | Depuy Ireland UC | 2025-05-23 |
| Frida™ Anterior Cervical Plate System (K250446) | Spineup, Inc. | 2025-05-23 |
| Knotilus+ Biocomposite Knotless Anchor (K250544) | Stryker Endoscopy | 2025-05-23 |
| TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (K250935) | TriMed, Inc. | 2025-05-22 |
| Trivicta® Hip Stem (K251052) | Ortho Development Corp. | 2025-05-22 |
| Physica System (Physica CR Porous Femoral components) (K250980) | Lima Corporate S.P.A. | 2025-05-22 |
| FlareHawk Interbody Fusion System (K243116) | Integrity Implants Inc. Dba Accelus | 2025-05-21 |
| Stryker AlphaVent™ Knotless SP Biocomposite Anchor (K250528) | Stryker Endoscopy | 2025-05-21 |
| X-PAC® N-GAGE™ Lumbar Plate System (K250602) | Expanding Innovations, Inc. | 2025-05-20 |
| Sovereign Posterior Cervical System (K250866) | Met One Technologies, LLC | 2025-05-20 |
| restor3d Reverse Total Shoulder Arthroplasty System (K243643) | Restor3D | 2025-05-19 |
| Arthrex Spine Endoscope (K243602) | Arthrex, Inc. | 2025-05-16 |
| Synthecure Synthetic Calcium Sulfate (K250141) | Austin Medical Ventures, Inc. | 2025-05-16 |
| MobileLink Acetabular Cup System - inhouse coatings (K243927) | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (K251184) | Encore Medical L.P. | 2025-05-16 |
| NEXUS® Hip Stem (K250444) | Microport Orthopedics, Inc. | 2025-05-15 |
| Linkt Compression Staple System (K250712) | Trax Surgical | 2025-05-14 |
| Freedom Posterior Cervical Screws (K242674) | Signature Orthopaedics Pty, Ltd. | 2025-05-13 |
| Shoulder Soft Tissue Anchors (K242477) | Signature Orthopaedics Pty, Ltd. | 2025-05-12 |
| Archer PSI System (K243509) | 3D-Side | 2025-05-12 |
| COLONNADE Posterior Screw Fixation System (K250582) | CG Bio Co., Ltd. | 2025-05-08 |
| NextStep Arthropedix Total Knee System (K242410) | Nextstep Arthropedix | 2025-05-08 |
| Extremity Medical External Fixation System (K251128) | Extremity Medical, LLC | 2025-05-07 |
| Origin™ Cemented Hip Stem (K243043) | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| APEX 3D Total Ankle Replacement System (K250641) | Paragon 28, Inc. | 2025-05-01 |
| Resolve Modular Revision Hip Stem (K242315) | United Orthopedic Corporation | 2025-05-01 |
| Stable-L Lumbar Interbody System (K243934) | Nexus Spine, LLC | 2025-04-30 |
| Pediatric Plating Platform Hip (K243963) | OrthoPediatrics Corp. | 2025-04-29 |
| Eminent Spine 3D Titanium Pedicle Screw System (K241663) | Eminent Spine | 2025-04-28 |
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| DYNAMIS™ Implant System (K251075) | Promethean Restorative, LLC | 2025-04-25 |
| CastleLoc Pectus Bar System (K250892) | L&K BIOMED Co., Ltd. | 2025-04-25 |
| Cervical Spine Truss System (CSTS) (K251117) | 4Web Medical | 2025-04-25 |
| CanMINI Hand and Foot System (K242973) | Canwell Medical Co., Ltd. | 2025-04-24 |
| Xpert Knee (K250155) | Newclip Technics | 2025-04-23 |
| Mpact 3D Metal Augments II (K242232) | Medacta International S.A. | 2025-04-23 |
| ARIX Femur Nail System (K242247) | Jeil Medical Corporation | 2025-04-22 |
| Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K250669) | Medtronic Sofamor Danek USA, Inc. | 2025-04-22 |
| Ventris Intervertebral Body Fusion Device (K243386) | Acuity Surgical Devices, LLC | 2025-04-22 |
| Zimmer Biomet Ceramic Heads (22.2mm diameter) (K250834) | Zimmer Biomet | 2025-04-18 |
| EXULT Knee Replacement System (K250889) | Corentec Co., Ltd. | 2025-04-17 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (K243537) | Xelite Biomed , Ltd. | 2025-04-11 |
| Medline UNITE® REFLEX® Hybrid Nitinol Implant System (K243888) | Medline Industries, LP | 2025-04-11 |
| Tesera-k SC System (K242928) | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| Skyway Anterior Cervical Plate System (K250486) | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| FitboneTM Trochanteric (K250112) | Orthofix Srl | 2025-04-10 |
| Initia T3 Acetabular Hemispherical Shell System (K242045) | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| TriMed® Compression Screws (K243943) | TriMed, Inc. | 2025-04-10 |
| ProLift Expandable Spacer System (K250373) | Life Spine, Inc. | 2025-04-09 |
| TriMed Fusion Cup System (K250948) | TriMed, Inc. | 2025-04-08 |
| NanoBone® SBX Putty ; NanoBone® QD (K250521) | Biocomposites, Ltd. | 2025-04-07 |
| Virage® OCT Spinal Fixation System (K250332) | Highridge Medical, LLC | 2025-04-04 |
| Spectrum Spine Lumbar Cage System (K243074) | Spectrum Spine, Inc. | 2025-04-04 |
| DeGen Medical Patient Specific Implant (PSI) System (K250667) | Degen Medical | 2025-04-04 |
| OSSIOfiber® Suture Anchor 2.5-3.5 mm (K243760) | OSSIO , Ltd. | 2025-04-03 |
| SPECTRUM GV Bone Cement (K250760) | Osteoremedies, LLC | 2025-04-02 |
| LEGION Total Knee System (K250677) | Smith & Nephew, Inc. | 2025-04-02 |
| SnapHammer Hammertoe Correction System (K250613) | Nvision Biomedical Technologies, Inc. | 2025-04-02 |
| Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (K250623) | OrthoPediatrics Corp. | 2025-04-01 |
| Arthrex FiberTak Suture Anchor (K250596) | Arthrex, Inc. | 2025-03-28 |
| CATALYSTEM Femoral Stems (K250571) | Smith & Nephew, Inc. | 2025-03-28 |
| iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768) | Restor3D, Inc. | 2025-03-27 |
| HC Biologics Osteopoint Spinal Fixation System (K250092) | HC Biologics, LLC | 2025-03-27 |
| Arthrex Humeral Plating System and Cerclage Button (K243995) | Arthrex, Inc. | 2025-03-26 |
| AxTiHA® Stand-Alone ALIF System (K250603) | Innovasis | 2025-03-24 |
| TIDAL Fusion Cage System (K242356) | Restor3D, Inc. | 2025-03-24 |
| Klassic Knee System - Revision Tibial Baseplate (K243991) | Total Joint Othopedics, Inc. | 2025-03-24 |
| GoLIF! Lumbar Interbody Fusion System (K250186) | Getset Surgical, SA | 2025-03-21 |
| Porous Biologic Scaffold (K250556) | Ventris Medical | 2025-03-21 |
| Catamaran SI Joint Fusion System (K250403) | Tenon Medical | 2025-03-21 |
| RootMend MRR (K243988) | Riverpoint Medical, LLC | 2025-03-20 |