| Flow-Nail (K234075) | Flow-Fx, LLC | 2024-02-05 |
| Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K234013) | Bone Solutions, Inc. | 2024-02-05 |
| OIC FLEX-FIX™ System (K233531) | Orthopaedic Implant Company | 2024-02-02 |
| VariTrax Sternal CircumFixation System (K232986) | Circumfix Solutions, Inc. | 2024-01-30 |
| E3D™-A Interbody System (K232432) | Evolution Spine | 2024-01-30 |
| Redemption Duo Hindfoot Nail System (K231343) | Vilex, LLC | 2024-01-30 |
| MONDRIAN™ Anterior Lumbar Plate System (K231715) | Ctl Medical Corporation | 2024-01-26 |
| iFuse Bedrock Granite® Implant System (K233508) | SI-BONE, Inc. | 2024-01-26 |
| Trigon Trigon HA Stand-Alone Wedge Fixation System (K234116) | Nvision Biomedical Technologies | 2024-01-26 |
| AlphaVent Knotless SP PEEK Anchor (K233893) | Stryker Endoscopy | 2024-01-25 |
| ADIRA™ Lateral Plate System (K233735) | Globus Medical, Inc. | 2024-01-25 |
| restor3d TIDAL Lumbar Interbody Fusion System (K234087) | Restor3D | 2024-01-22 |
| RESPONSE™ Rib and Pelvic System (K233105) | OrthoPediatrics Corp. | 2024-01-20 |
| MagnetOs Granules (K232347) | Kuros Biosciences B.V | 2024-01-19 |
| IlluminOss Photodynamic Bone Stabilization System (K233436) | Illuminoss Medical, Inc. | 2024-01-19 |
| DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (K231873) | Depuy Ireland UC | 2024-01-19 |
| TORPEDO Implant System® (K230817) | Deltacor GmbH | 2024-01-19 |
| HKT Anatomical Locking Trauma System (K231213) | Hankil Tech Medical Co., Ltd. | 2024-01-19 |
| EVOLUTION® Tibial Cones (K233507) | Microport Orthopedics, Inc. | 2024-01-18 |
| Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 (K234051) | Spinal Simplicity, LLC | 2024-01-18 |
| Curiteva Porous PEEK Lumbar Interbody Fusion System (K233744) | Curiteva, Inc. | 2024-01-18 |
| TriMed Threaded Intramedullary Nail System (K234040) | TriMed, Inc. | 2024-01-18 |
| TDM Screw System (K231860) | Tdm Co., Ltd. | 2024-01-18 |
| AMF TT Cones (K234011) | Lima Corporate S.P.A. | 2024-01-18 |
| Medline UNITE Ancillary Foot Recon Plating System (K234031) | Medline Industires, LP | 2024-01-18 |
| Footprint Mini PK, 3.5mm Suture Anchor (K233730) | Smith & Nephew | 2024-01-17 |
| Osteoboost Belt (DEN230015) | Bone Health Technologies, Inc. | 2024-01-12 |
| A’TOMIC™ Nitinol Fixation System (K232990) | Rmr Ortho, LLC | 2024-01-12 |
| BEE Cervical Cage (K231371) | NGMedical GmbH | 2024-01-12 |
| Quick - Radius Disposable Set (K231684) | GM Dos Reis Industria e Comercio Ltda. | 2024-01-12 |
| Meridian Interbody System; WaveForm A Interbody System (K233694) | SeaSpine Orthopedics Corporation | 2024-01-12 |
| PRIMA Humeral System; PRIMA TT Glenoid (K233712) | Lima Corporate S.P.A. | 2024-01-11 |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (K233944) | CarboFix Orthopedics , Ltd. | 2024-01-10 |
| CEPTRE® Knotted UHMWPE Suture PEEK Anchor (K231033) | Healthium Medtech Limited | 2024-01-04 |
| Zimed Distal Medial Tibial Plate and Screw System (K230507) | Zimed Medikal | 2024-01-04 |
| SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant (K230891) | Healthium Medtech Limited | 2023-12-28 |
| Suture Wing (K233659) | Osteonic Co., Ltd. | 2023-12-26 |
| POWEReam 1/4 Drive (K233300) | Stryker Instruments | 2023-12-26 |
| Novae® Dual Mobility System, Hype® Hip System (K223745) | Serf | 2023-12-22 |
| Hoffmann LRF System (K233741) | Stryker GmbH | 2023-12-21 |
| Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (K233423) | Tyber Medical, LLC | 2023-12-21 |
| Stryker Orthopaedics Hip Systems Labeling Update (K233498) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-12-21 |
| SMR Hybrid Glenoid System (K231099) | Lima Corporate S.P.A. | 2023-12-21 |
| SkyOPS™ Orthopedic Plate System (K233154) | Sky Surgical, LLC | 2023-12-21 |
| Cannulated Screw System (K233396) | Smith & Nephew, Inc. | 2023-12-21 |
| MagnetOs Putty (K230736) | Kuros Biosciences B.V | 2023-12-20 |
| SPECTRUM® GV Bone Cement (K231556) | Osteoremedies, LLC | 2023-12-20 |
| Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system (K233839) | Gbs Commonwealth Co., Ltd. | 2023-12-20 |
| United Orthopedic Knee Patient Specific Instrumentation (K230850) | Enhatch, Inc. | 2023-12-20 |
| TM Plating System (K233017) | Tyber Medical, LLC | 2023-12-20 |
| Tactoset® Injectable Bone Substitute (K231968) | Anika Therapeutics, Inc. | 2023-12-20 |
| CORAIL Cemented Femoral Stem (K231526) | Depuy Ireland UC | 2023-12-19 |
| CC-Clip® Implant System (K232780) | Cc-Instruments, Inc. | 2023-12-18 |
| Internal Locking Plate and Screw Fixation System (K232394) | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023-12-15 |
| MagnetOs Easypack Putty (K233607) | Kuros Biosciences B.V | 2023-12-15 |
| Precice Max System (K232267) | Nuvasive Specialized Orthopedics, Incorporated | 2023-12-15 |
| Double Internal Joint Stabilizer- Elbow (K231447) | Skeletal Dynamics, Inc. | 2023-12-15 |
| Ascension Silicone MCP; Ascension Silicone PIP (K233670) | Ascension Orthopedics, Inc. | 2023-12-14 |
| ARIX Ankle Distal Tibia System (K231887) | Jeil Medical Corporation | 2023-12-14 |
| Anatomical Plating System (various) (K232652) | Tyber Medical, LLC | 2023-12-13 |
| Genesys Spine 3DP AIS-C II Cervical Interbody System (K233594) | Genesys Spine | 2023-12-13 |
| Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (K230872) | Shanghai Sanyou Medical Co, Ltd. | 2023-12-12 |
| TriALTIS™ Spine System (K233684) | Medos International SARL | 2023-12-12 |
| ARx MIS Spinal Screw System (K233455) | Life Spine, Inc. | 2023-12-12 |
| Signature™ ONE System (K232425) | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K232303) | Depuy Ireland UC | 2023-12-11 |
| F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (K231743) | Corelink, LLC | 2023-12-08 |
| Global Modular Replacement System (K233261) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| Valkyrie Thoracic Fixation System (K232515) | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | 2023-12-08 |
| MySpine Cervical Guides (K231515) | Medacta International S.A. | 2023-12-07 |
| OTS 25 (100-1) (K233429) | Ots Medical , Ltd. | 2023-12-07 |
| SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490) | Bioventus, LLC | 2023-12-05 |
| Liberty SI Lateral Implant System (K231923) | Spinal Simplicity, LLC | 2023-12-05 |
| arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (K230724) | Novastep | 2023-12-04 |
| Tyber Medical Distal Radius Plating System (K232693) | Tyber Medical, LLC | 2023-12-04 |
| Align Cervical Interbody Fusion System (K230639) | Acuity Surgical Devices, LLC | 2023-12-01 |
| OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (K231272) | OSSIO , Ltd. | 2023-12-01 |
| TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System (K232611) | Life Spine, Inc. | 2023-11-30 |
| IDEAL Ziploop (K233552) | Riverpoint Medical | 2023-11-30 |
| Auxein's DHS/DCS Plate System (K221787) | Auxein Medical Private Limited | 2023-11-30 |
| Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate (K233527) | Spinal Simplicity, LLC | 2023-11-29 |
| Expandable Lumbar Fusion Cage (Type I,Type II) (K232069) | Shanghai Reach Medical Instrument Co, Ltd. | 2023-11-29 |
| Shoreline ACS Interbody System; Shoreline RT Interbody System (K233414) | SeaSpine Orthopedics Corporation | 2023-11-28 |
| Kinos Axiom Total Ankle System (K232595) | Restor3D | 2023-11-28 |
| Statera-C™ Spinal System (K233332) | K&J Consulting Corp. | 2023-11-27 |
| Posterior Cervical Spine System (K233078) | Double Medical Technology, Inc. | 2023-11-22 |
| PNK Total Knee System (K231975) | Tjc Life Co., Ltd. | 2023-11-21 |
| Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (K233084) | Gbs Commonwealth Co., Ltd. | 2023-11-21 |
| TotalTi ACDF by SAGICO (K233191) | Spinal Analytics & Geometrical Implant Co, LLC | 2023-11-21 |
| Mini-OSTEO Pedicle Fixation System (K231443) | Osteomed Indústria E Comércio DE Implantes Ltda | 2023-11-21 |
| ProMIS Extension Rod System (K232719) | Premia Spine, Ltd. | 2023-11-21 |
| MagnetOs Flex Matrix (K233245) | Kuros Biosciences B.V | 2023-11-21 |
| MASADA Modular Spinal Fixation System (K231694) | Astura Medical | 2023-11-16 |
| OSSIOfiber® Compression Staple (K233302) | OSSIO , Ltd. | 2023-11-16 |
| LINK Embrace Shoulder System - Reverse Configuration (K231445) | Waldemar Link GmbH & Co. KG | 2023-11-16 |
| Arthrex Knee FiberTak® Button Suture Anchor (K232973) | Arthrex, Inc. | 2023-11-15 |
| Iconix Anchor (K233468) | Riverpoint Medical | 2023-11-14 |
| INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831) | Depuy Ireland UC | 2023-11-13 |
| SYMPHONY OCT System (K233366) | Medos International SARL | 2023-11-09 |
| Glenoid Reconstruction System – Full Wedge Baseplate (K231911) | Medacta International S.A. | 2023-11-09 |