| MAXXOS P.A.C.E. Foot & Ankle Plating System (K251892) | Maxxos Medical GmbH | 2025-09-08 |
| All-Suture Dual Anchor System (K250095) | Suturetech, Inc. | 2025-09-05 |
| Endoskeleton™ Interbody Systems (K251444) | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 |
| Kinos Total Ankle System (K252454) | Restor3D | 2025-09-03 |
| IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (K251575) | Alphatec Spine | 2025-09-03 |
| Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (K251975) | Ignite Orthomotion | 2025-09-02 |
| CurvaFix Low Profile System (K252019) | Curvafix, Inc. | 2025-08-29 |
| ArTT Augments and Buttresses and Bone Screws (K251718) | Lima Corporate S.P.A. | 2025-08-29 |
| IVA & AEON Cervical and Lumbar Cage System (K250335) | K&J Consulting | 2025-08-29 |
| JAZZ Spinal System (K252437) | Implanet | 2025-08-28 |
| JARVIS Glenoid Reverse Shoulder Prosthesis (K252411) | FH Industrie | 2025-08-28 |
| Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965) | Alphatec Spine, Inc. | 2025-08-28 |
| Phoenix Sinus Tarsi Stent System (K251382) | Astra Orthomed, Inc. | 2025-08-27 |
| ELID (Endoscopic Less Invasive Decompression) System (K243774) | Lesspine Innovations | 2025-08-27 |
| Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634) | Maxx Orthopedics, Inc. | 2025-08-25 |
| Stem Extension Line (USTAR II System) (K252303) | United Orthopedic Corporation | 2025-08-22 |
| Treace Medical Concepts (TMC) Implant Fixation System (K251135) | Treace Medical Concepts | 2025-08-21 |
| The Acumed Wrist Fixation System - 2.4mm Screws (K252356) | Acumed, LLC | 2025-08-21 |
| Fine Osteotomy™ (K250923) | Bodycad Laboratories, Inc. | 2025-08-21 |
| T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (K251400) | Stryker GmbH | 2025-08-20 |
| Distal Xtremities System (K252061) | TriMed, Inc. | 2025-08-20 |
| OSSIOfiber® Interference Screw (K252022) | OSSIO , Ltd. | 2025-08-19 |
| ANTHEM® Fracture System (K251161) | Globus Medical, Inc. | 2025-08-18 |
| OsteoCentric® UnifiMI® TCS Plating System (K251913) | OsteoCentric Technologies | 2025-08-16 |
| Atlas Spine Project X Expandable Posterior Lumbar Interbody System (K251969) | Atlas Spine, Inc. | 2025-08-15 |
| Persona Partial Knee (K251834) | Zimmer Biomet | 2025-08-15 |
| KLS Martin Ixos System (K250620) | KLS Martin L.P. | 2025-08-15 |
| Dunamis Screw and Suture Locking System (K250867) | Dunamis Medical, LLC | 2025-08-15 |
| Stitch Cerclage – Suture Tapes (K243905) | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 |
| T2 Alpha Femur Retrograde Nailing System (K250163) | Stryker GmbH | 2025-08-13 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| Identity Revision Humeral Stems (K251098) | Zimmer, Inc. | 2025-08-11 |
| SABER-C System (K250540) | Elevation Spine | 2025-08-08 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) | Amdt Holdings, Inc. | 2025-08-08 |
| Longboard Revision Hip Stem (K243021) | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| Succession™ AFN System (K250622) | Ortho Solutions UK , Ltd. | 2025-08-07 |
| Aevumed PHANTOM Suture Anchors (K242895) | Aevumed, Inc. | 2025-08-06 |
| InterSpace GV Hip Spacer (K252326) | Tecres S.P.A. | 2025-08-06 |
| PRADO™ Lumbar Interbody Fusion System (K252113) | Bethesda Medical Devices | 2025-08-05 |
| AltiVate Reverse® Glenoid (K252141) | Encore Medical L.P. | 2025-08-05 |
| Equinoxe® Shoulder System (K243448) | Exactech, Inc. | 2025-08-01 |
| RONAVIS – FX (FX-001) (K250315) | AIRS, Inc. | 2025-08-01 |
| Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571) | Zimmer Biomet | 2025-07-31 |
| U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656) | United Orthopedic Corporation | 2025-07-31 |
| Mpact Constrained Liner (K241461) | Medacta International S.A. | 2025-07-31 |
| Stabilis SA Cervical Stand-Alone System (Various PNs) (K251735) | Acuity Surgical Devices, LLC | 2025-07-30 |
| SpineSite Endoscope System (K241990) | Hydrocision, Inc. | 2025-07-30 |
| Tyber Medical Distal Radius Plating System (K251361) | Tyber Medical, LLC | 2025-07-30 |
| Iconix Speed Anchor; Iconix Speed HA+ Anchor (K252144) | Riverpoint Medical | 2025-07-30 |
| SImmetry+ System (K250647) | Sivantage | 2025-07-29 |
| Triathlon® Hinge Knee System (K251665) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-07-25 |
| A.L.P.S. Proximal Humerus Plating System (K251620) | Zimmer Biomet | 2025-07-25 |
| Stryker and Serf hip devices (K250989) | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| MOTO Partial Knee System Extension (K251618) | Medacta International S.A. | 2025-07-24 |
| OTS 25-L (100-5) (K251310) | Ots Medical , Ltd. | 2025-07-22 |
| Arthrex FiberTak Suture Anchor (K251809) | Arthrex, Inc. | 2025-07-18 |
| Z1 Hip System (K251906) | Zimmer, Inc. | 2025-07-18 |
| Baby Gorilla®/Gorilla® Plating System (K250952) | Paragon 28, Inc. | 2025-07-18 |
| MectaLIF 3D Metal (K251016) | Medacta International S.A. | 2025-07-17 |
| Device 300423 Granules (K251556) | Geistlich Pharma AG | 2025-07-17 |
| Materialise TKA Guide System (K251554) | Materialise NV | 2025-07-14 |
| Phantom® Hindfoot TTC/TC Nail System (K251850) | Paragon 28, Inc. | 2025-07-14 |
| The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (K251132) | Acumed, LLC | 2025-07-14 |
| Resolve Anterior Cervical Plate System (K251436) | Pioneer Surgical Technology, Inc. | 2025-07-11 |
| RipCord (K251134) | TriMed, Inc. | 2025-07-11 |
| CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072) | Avalign Technologies, Inc. | 2025-07-10 |
| Arthrex PushLock Suture Anchors (K251145) | Arthrex, Inc. | 2025-07-10 |
| TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (K251945) | TriMed, Inc. | 2025-07-10 |
| panaSIa SI Fusion System (K250247) | Wenzel Spine, Inc. | 2025-07-09 |
| EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (K251776) | Encore Medical L.P. | 2025-07-08 |
| PathLoc Lumbar Interbody Fusion Cage System (K251741) | L&K BIOMED Co., Ltd. | 2025-07-08 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K251804) | S.M.A.I.O | 2025-07-08 |
| TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (K251502) | Life Spine, Inc. | 2025-07-07 |
| aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (K250827) | Carlsmed, Inc. | 2025-07-07 |
| SMR Reverse HP Shoulder System (K243826) | Lima Corporate S.P.A. | 2025-07-03 |
| IdentiTi II Cervical Interbody System (K251080) | Alphatec Spine, Inc. | 2025-07-03 |
| OsteoFlo HydroFiber (K251720) | SurGenTec, LLC | 2025-07-02 |
| EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (K251241) | Encore Medical L.P. | 2025-07-02 |
| Identity Shoulder System (K250848) | Zimmer, Inc. | 2025-07-02 |
| Momentum® Posterior Spinal Fixation System (K251719) | Ulrich Medical USA, Inc. | 2025-07-01 |
| Arthrex iBalance Partial Knee System (K251453) | Arthrex, Inc. | 2025-07-01 |
| SnugFit ASA Extension (K251933) | Medacta International S.A. | 2025-07-01 |
| aprevo® posterior/transforaminal lumbar interbody fusion device (K250987) | Carlsmed, Inc. | 2025-06-30 |
| FIX-C PEEK ACIF SA System (K251431) | Jeil Medical Corporation | 2025-06-27 |
| Genostis Osteosynthesis System (K242988) | Genostis AF | 2025-06-27 |
| Testa TP Pivoting Spacer System (K243816) | Spine Wave, Inc. | 2025-06-27 |
| Freedom® Total Knee System – Titanium Tibial Base Plate (K251717) | Maxx Orthopedics, Inc. | 2025-06-26 |
| The Rialto™ SI Fusion System (K251395) | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 |
| TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) (K250929) | TriMed, Inc. | 2025-06-26 |
| Equinoxe® Scapula Fracture System (K243275) | Exactech, Inc. | 2025-06-26 |
| X-PAC® LLIF Expandable Lateral Cage System (K251003) | Expanding Innovations, Inc. | 2025-06-25 |
| CORIOGRAPH Pre-Op Planning and Modeling Services (K250921) | Blue Belt Technologies, Inc. | 2025-06-25 |
| ANAX™ OCT Spinal System (K251725) | Cg Medtech Co., Ltd. | 2025-06-25 |
| BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) (K251627) | Smith & Nephew, Inc. | 2025-06-25 |
| PediFlex™ Flexible Nail System (K251362) | OrthoPediatrics Corp. | 2025-06-24 |
| ProAM ALIF System (K251644) | Pro Surgical, Inc. | 2025-06-24 |
| Incompass Total Ankle System (K250037) | Wright Medical Technology, Inc. (Stryker) | 2025-06-20 |
| Virata Spinal Fixation System (K250908) | SeaSpine Orthopedics Corporation | 2025-06-18 |
| The Acumed Wrist Fixation System (K251296) | Acumed, LLC | 2025-06-18 |
| CONMED Argo Knotless® Anchor (K251530) | Conmed Corporation | 2025-06-18 |