| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253721) | S.M.A.I.O | 2025-12-17 |
| Cambridge Partial Knee (K251771) | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K251302) | Spineology, Inc. | 2025-12-15 |
| Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (K252898) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-12-15 |
| Affixus® Natural Nail® Proximal Humeral System (K253749) | Zimmer Switzerland Manufacturing GmbH | 2025-12-12 |
| HyperFlex® Bunion Correction System (K252997) | Hyperflex Medical | 2025-12-11 |
| KLS Martin Pure Pectus System (K250988) | KLS-Martin L.P. | 2025-12-11 |
| APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista (K252897) | A Plus Biotechnology Co., Ltd. | 2025-12-11 |
| Cervical Spine Truss System - Stand Alone (CSTS-SA) (K253200) | 4Web Medical, Inc. | 2025-12-11 |
| ARIX Femur Nail System (K252826) | Jeil Medical Corporation | 2025-12-10 |
| DeGen Medical Patient Specific Implant (PSI) System (K251829) | Degen Medical | 2025-12-08 |
| Velora Acetabular System (K252067) | Restor3D, Inc. | 2025-12-05 |
| SpineLinc Anterior Cervical Implant System (K250764) | Lincotek Medical | 2025-12-05 |
| PUREVUE™ FMS (K250795) | W.O.M. World of Medicine GmbH | 2025-12-05 |
| VSP Orthopedics System (K250711) | 3D Systems, Inc. | 2025-12-05 |
| Tigon Medical Knotless and Dual Javelin All-Suture Anchors (K252596) | Tigon Medical | 2025-12-04 |
| Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713) | Exactech, Inc. | 2025-12-01 |
| Minuteman® G6 MIS Fusion Plate (K253250) | Spinal Simplicity, LLC | 2025-12-01 |
| Medusa Orthopedics Boa External Fixation System (K252555) | Medusa Orthopedics, LLC | 2025-11-25 |
| ZSFab Lumbar Interbody System (K252610) | Zsfab, Inc. | 2025-11-25 |
| Dakota LP System (K250769) | Precision Spine, Inc. | 2025-11-24 |
| BEE HA (K250560) | NGMedical GmbH | 2025-11-21 |
| EffortMed PEEK Cages & Corpectomy Cages (K252686) | Effortmed, LLC | 2025-11-21 |
| Articulator Arthroscopic Bur (K252666) | Joint Preservation Innovations, LLC | 2025-11-21 |
| TaperSet™ Hip System (K252846) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| The Response Ortho Smart Fixator - Hexapod System (K252625) | Response Ortho Solutions, LLC | 2025-11-20 |
| OptumSI Implant System (K251365) | Si Solutions, LLC | 2025-11-20 |
| ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197) | Depuy Ireland UC | 2025-11-19 |
| SternaFuse Ti Fixation System (K252661) | Fusion Innovations, LLC | 2025-11-19 |
| MyPAO SA guides (K242603) | Medacta International S.A. | 2025-11-19 |
| Universal Spinal System (K252729) | Double Medical Technology, Inc. | 2025-11-18 |
| ToeJack MIS Bunion System (K253423) | Nvision Biomedical Technologies, Inc. | 2025-11-18 |
| KLS Martin IPS Forearm System (K250865) | KLS-Martin L.P. | 2025-11-14 |
| Geminus Volar Distal Radius Plating System (K252949) | Skeletal Dynamics, Inc. | 2025-11-13 |
| CMORE® CT System; CMORE® CT System Navigated Instruments (K252327) | Icotec AG | 2025-11-12 |
| WRISTAR MultiAx Distal Radius Kit (K252959) | Intrauma S.P.A | 2025-11-12 |
| EMPOWR Acetabular® Liner Extension (K251833) | Encore Medical L.P. | 2025-11-12 |
| Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (K252560) | Atlas Spine, Inc. | 2025-11-10 |
| Catalyst F1x Shoulder System (K252418) | Catalyst Orthoscience, Inc. | 2025-11-06 |
| Ultra™ Compression Screw System (K251555) | Pace Surgical | 2025-11-06 |
| Allure Hip Stem and Intramedullary Plugs (K250375) | Waldemar Link GmbH & Co. KG | 2025-11-05 |
| GMReis Suture Anchors (K252664) | GM Dos Reis Industria e Comercio Ltda. | 2025-11-04 |
| MedCAD® AccuStride™ System (K251709) | Medcad | 2025-11-04 |
| Kyphoplasty Balloon Dilatation Catheters (K252458) | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777) | Maxx Orthopedics, Inc. | 2025-10-31 |
| MSS - Humeral reverse liners extension (K250338) | Medacta International S.A. | 2025-10-31 |
| Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686) | Tornier, Inc. | 2025-10-30 |
| Arthrex SutureTak Suture Anchor (K252314) | Arthrex, Inc. | 2025-10-29 |
| Freedom Infinia™ Total Knee System (K253314) | Maxx Orthopedics, Inc. | 2025-10-29 |
| AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416) | Smith & Nephew, Inc. | 2025-10-29 |
| Synchfix EVT (K251643) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 |
| Meduloc Intramedullary Fracture Fixation (IFF) System (K250316) | Meduloc, LLC | 2025-10-29 |
| JARVIS Diaphyseal Stem Standard (K253345) | FH Industrie | 2025-10-29 |
| Fine Osteotomy™ (K253300) | Bodycad Laboratories, Inc. | 2025-10-28 |
| UniSpace® TPLIF Cage (K252351) | Cg Medtech Co., Ltd. | 2025-10-28 |
| Infinity™ OCT System (K253129) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| Fule Spinal Fixation System (K252730) | Beijing Fule Science & Technology Development Co., Ltd. | 2025-10-24 |
| Expandable Titanium PLIF/TLIF System (K253377) | Spectrum Spine, Inc. | 2025-10-24 |
| Triathlon® Total Knee System - Triathlon® Gold Femoral Components (K252044) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute (K253147) | Prosidyan, Inc. | 2025-10-22 |
| Freedom® Total Knee System – Titan PCK Components (K253144) | Maxx Orthopedics, Inc. | 2025-10-22 |
| SIros-X System (K252322) | Genesys Spine | 2025-10-22 |
| Aevumed FASE Suture Anchor (K253040) | Aevumed, Inc. | 2025-10-21 |
| Fine TTO™ (K250394) | Bodycad Laboratories, Inc. | 2025-10-21 |
| TriALTIS™ Spine System (K253249) | Medos International SARL | 2025-10-21 |
| OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252346) | Astura Medical | 2025-10-21 |
| A8 INTEGR8™ Porous Pedicle Screws (K242827) | Allumin8, Inc. | 2025-10-20 |
| Estremo Fibular Nail (K250197) | Citieffe S.R.L. | 2025-10-17 |
| Osteotomy Wedge System (K252254) | Sinaptic Surgical | 2025-10-17 |
| BioBrace® Extra-Articular Ligament Augmentation Kit (K252946) | Conmed Corporation | 2025-10-15 |
| ELEOS™ Limb Salvage System with NanoCept® Technology (K252920) | Onkos Surgical, Inc. | 2025-10-15 |
| TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (K252020) | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| PressON Spinal Fixation System (K253331) | Nexus Spine | 2025-10-14 |
| Mini Superhawk Suture Anchor System (K253010) | Responsive Arthroscopy, LLC | 2025-10-14 |
| Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K251522) | Bone Solutions, Inc. | 2025-10-13 |
| DeGen Medical Latitude-C AM Cervical Interbody Fusion System (K252737) | Degen Medical | 2025-10-10 |
| Eleganz IM Threaded Nail System (IM Threaded Nail System) (K252312) | Dev4 | 2025-10-10 |
| iFuse Bedrock Granite Implant System (K253094) | SI-BONE, Inc. | 2025-10-09 |
| Pediatric Plating Platform I Small-Mini (K252600) | OrthoPediatrics Corp. | 2025-10-09 |
| MetaFore Small Screw System (K250536) | Extremity Medical, LLC | 2025-10-08 |
| Eminent Spine Posterior SI System (K250894) | Eminent Spine | 2025-10-07 |
| AETOS Shoulder System Stemless Humeral Prosthesis (K252129) | Smith & Nephew, Inc. | 2025-10-03 |
| Cannulated Screw and Kirschner (K wire) System (K252758) | Orthonovis, Inc. | 2025-10-02 |
| Newclip Patient-matched instrumentation non sterile PSI (K250767) | Newclip Technics | 2025-10-01 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (K252085) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-09-30 |
| UltraGuideCTR® image guided soft tissue release system (K252594) | Sonex Health | 2025-09-29 |
| Inset Reverse Total Shoulder System (K252221) | Shoulder Innovations, Inc. | 2025-09-26 |
| Stem Extension Line (U2 Total Knee System—PSA Type) (K252725) | United Orthopedic Corporation | 2025-09-25 |
| Auxano® Wedge Fixation System (K251791) | Auxano Medical, LLC | 2025-09-25 |
| Endeavor™ Stand-Alone Cervical IBF System (K250076) | Innovasis | 2025-09-25 |
| Coated hip implants (K250450) | Medacta International S.A. | 2025-09-19 |
| Impact PEEK Union Nail System (K252657) | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) (K251479) | Mobarn Medical Devices, LLC | 2025-09-18 |
| Ruthless Spine RJB (K252615) | Ruthless, LLC Dba Ruthless Spine | 2025-09-17 |
| SpaceFix Shoulder Spacer (K252443) | G21, S.R.L. | 2025-09-15 |
| DynaNail TTC Fusion System (K250628) | MedShape, Inc. | 2025-09-12 |
| OsteoProbe (OP-100) (K250216) | Active Life Scientific, Inc. | 2025-09-11 |