| KeYi Total Knee System (K230120) | Beijing Keyi Medical Device Technology Co., Ltd. | 2024-04-19 |
| Patriot-SI Posterior Implant System (K232259) | Spinal Simplicity, LLC | 2024-04-19 |
| APTUS Foot System 2.8-3.5 (K232105) | Medartis AG | 2024-04-19 |
| UniSpace® Stand-Alone C Cage (K234119) | Innosys Co., Ltd. | 2024-04-19 |
| NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System (K232566) | SeaSpine Orthopedics Corporation | 2024-04-19 |
| Ethylene Oxide Sterilization Supplier Change for MPO Hips (K240046) | Microport Orthopedics | 2024-04-18 |
| MSFX Mikron Cervical Anterior Plate System (K240484) | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 |
| TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- (K233863) | TriMed, Inc. | 2024-04-17 |
| Alcantara Thoracolumbar Plate System (K232256) | Camber Spine Technologies, LLC | 2024-04-16 |
| XN Knee Prosthesis System (K232175) | Beijing Chunlizhengda Medical Instruments Co., Ltd. | 2024-04-14 |
| Stryker Orthopaedics Hip Systems Labeling Update (K240418) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| Fine Osteotomy™ (K240703) | Bodycad Laboratories, Inc. | 2024-04-12 |
| Ceramic Femoral Head (K240452) | Microport Orthopedics, Inc. | 2024-04-12 |
| TiLink-P SI Joint Fusion System (K240720) | SurGenTec, LLC | 2024-04-11 |
| OC JuggerKnot Soft Anchor (K240719) | Riverpoint Medical | 2024-04-11 |
| Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (K233509) | Zavation Medical Products, LLC | 2024-04-10 |
| TDM Anterior Cervical Plate System (K240423) | Tdm Co., Ltd. | 2024-04-08 |
| ELEOSx™ Limb Salvage System (DEN210058) | Onkos Surgical | 2024-04-05 |
| TDM Large Bone Plate and Screw System (K232115) | Tdm Co., Ltd. | 2024-04-05 |
| Orthobond Mariner Pedicle Screw System (DEN220015) | Orthobond Coporation | 2024-04-05 |
| icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (K232792) | Icotec AG | 2024-04-05 |
| Catalyst F1x Shoulder System (K234105) | Catalyst Orthoscience, Inc. | 2024-04-05 |
| G Surgical Marksman MIS System (K240737) | G Surgical, LLC | 2024-04-05 |
| PINNACLETM Constrained Acetabular Liners (K240639) | Depuy Ireland UC | 2024-04-04 |
| KONG®-TL VBR System and KONG® C VBR System (K232790) | Icotec AG | 2024-04-04 |
| TRIBRID® Unicompartmental Knee System (K232114) | Kyocera Medical Technologies, Inc. | 2024-04-04 |
| Vertex Hip Fracture Nailing System (K233910) | Orthoxel Dac | 2024-04-04 |
| AnyPlus II Spinal Fixation System (K240350) | GS Medical Co., Ltd. | 2024-04-03 |
| EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (K240043) | Microport Orthopedics, Inc. | 2024-04-01 |
| SF Push- in Anchor (K240288) | Surgical Fusion Technologies GmbH | 2024-04-01 |
| MagnetOs Putty (K240442) | Kuros Biosciences B.V | 2024-04-01 |
| CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (K233951) | Medtronic Sofamor Danek USA, Inc. | 2024-03-27 |
| CarboClear® Posterior Cervical Screw System (K233989) | CarboFix Orthopedics , Ltd. | 2024-03-27 |
| Lucent® XP (K234150) | Spinal Elements | 2024-03-27 |
| Grappler Suture Anchor R3FLEX IOL System (K240594) | Paragon 28, Inc. | 2024-03-26 |
| VariAx 2 Distal Radius System (K233919) | Stryker GmbH | 2024-03-25 |
| Augment Off-Axis Instrument System (K233148) | Fix Surgical | 2024-03-22 |
| aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device (K232282) | Carlsmed, Inc. | 2024-03-22 |
| Idys® C ZP 3DTi (K240715) | Clariance | 2024-03-22 |
| FITBONE® Transport and Lengthening System (K232169) | Orthofix Srl | 2024-03-22 |
| STRUXXURE® MCS Anterior Cervical Plate System (K240690) | Nexxt Spine | 2024-03-22 |
| APTUS Hand Scaphoid Plates (K234062) | Medartis AG | 2024-03-21 |
| ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980) | Depuy Ireland UC | 2024-03-21 |
| DynaNail Mini Tapered Hybrid (K240530) | MedShape, Inc. | 2024-03-21 |
| Ankle Truss System (ATS) (K230088) | 4Web Medical, Inc. | 2024-03-21 |
| DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (K233665) | DePuy Synthes | 2024-03-21 |
| Tranquil-L Interbody System (K233375) | Nexus Spine, LLC | 2024-03-20 |
| NuVasive AttraX Scaffold (K240507) | Nuvasive, Inc. | 2024-03-20 |
| MATRIX HA PEEK Cervical IBF System (K232619) | Sapphire Medical Group | 2024-03-19 |
| uNion® MAX Cervical Plate System (K240515) | Ulrich Medical USA, Inc. | 2024-03-18 |
| CORIOGRAPH Knee Pre-Op Plan (K240113) | Smith & Nephew, Inc. | 2024-03-18 |
| MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (K240441) | Depuy Mitek | 2024-03-15 |
| Vital™ Spinal Fixation System (K240539) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-03-15 |
| QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (K231850) | Globus Medical, Inc. | 2024-03-14 |
| CERAMENT G (K234008) | Bonesupport AB | 2024-03-13 |
| BioPoly Radial Head Implant (K233592) | BioPoly, LLC | 2024-03-13 |
| ACCORD Cable System (K233949) | Smith & Nephew, Inc. | 2024-03-13 |
| Tranquil-C Interbody System (K240416) | Nexus Spine, LLC | 2024-03-12 |
| Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (K240424) | Collagen Matrix, Inc. | 2024-03-12 |
| ARIX Cannulated Screw System (K233912) | Jeil Medical Corporation | 2024-03-11 |
| 28mm/38D MDM X3 Insert for MDM Liner (K233724) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-03-11 |
| Trivicta™ Hip Stem (K233758) | Ortho Development Corp. | 2024-03-08 |
| OSSIOfiber® Threaded Trimmable Fixation Nails (K233198) | OSSIO , Ltd. | 2024-03-08 |
| DOMINION Expandable Corpectomy System (K233359) | Astura Medical | 2024-03-08 |
| ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor (K240407) | Stryker Endoscopy | 2024-03-07 |
| Synthetic Bone Putty (K240458) | Ventris Medical | 2024-03-07 |
| “BioGend” Interbody Fusion System 001 Cage (K233075) | Biogend Therapeutics Co., Ltd. | 2024-03-06 |
| Cerament Bone Void Filler (K240459) | Bonesupport AB | 2024-03-05 |
| NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) (K240404) | Novabone Products, LLC | 2024-03-05 |
| Argo Knotless GENESYS Anchor (K240090) | Conmed Corporation | 2024-03-05 |
| ReBOSSIS (K240453) | Orthorebirth Co., Ltd. | 2024-03-04 |
| Balloon Inflation System (K232842) | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 |
| Curiteva Thoracolumbar Plate System (K233360) | Curiteva, Inc. | 2024-02-29 |
| Accu-Joint Hemi Implant (K240268) | Accufix Surgical, Inc. | 2024-02-29 |
| Camber Sacroiliac (SI) Fixation System (K233972) | Camber Spine Technologies | 2024-02-27 |
| 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM (K232607) | Solco Biomedical Copany India Private Limited | 2024-02-27 |
| VADER® Pedicle System (K232628) | Icotec AG | 2024-02-26 |
| FMS VUE™ Fluid Management and Tissue Debridement System (K233675) | DePuy Mitek, Inc. | 2024-02-26 |
| Iconix Knotless Anchor (K240213) | Riverpoint Medical | 2024-02-23 |
| PathLoc SI Joint Fusion System (K240201) | L&K BIOMED Co., Ltd. | 2024-02-23 |
| COGNiTiON™ Staple System (K240212) | Ortho Solutions UK , Ltd. | 2024-02-23 |
| Treace Medical Systems (TMC) Plating System (K240173) | Treace Medical Concepts, Inc. | 2024-02-22 |
| Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (K233640) | Alphatec Spine, Inc. | 2024-02-22 |
| BLUEPRINT™ Patient Specific Instrumentation (K232265) | Tornier S.A.S. | 2024-02-21 |
| ProCinch, QuadCinch (K240194) | Riverpoint Medical | 2024-02-21 |
| NET BRAND Osteosynthesis Nailing System (K233150) | Narang Medical , Ltd. | 2024-02-20 |
| AGILON® XO Shoulder Replacement System (K231657) | Implantcast GmbH | 2024-02-16 |
| SnapHammer Hammertoe Correction System (K231453) | Nvision Biomedical Technologies, Inc. | 2024-02-16 |
| COPAL® exchange G hip spacer; COPAL® G+V (K234028) | Heraeus Medical GmbH | 2024-02-15 |
| EMPHASYS™ Dual Mobility System (K231522) | Depuy Ireland UC | 2024-02-15 |
| VerteLoc Spinal System (K231134) | Signature Orthopaedics Pty, Ltd. | 2024-02-13 |
| M.U.S.T. Pedicle Screw System - Extension (K234048) | Medacta International S.A. | 2024-02-13 |
| Univers Revers CA Head and Adapter (K233260) | Arthrex, Inc. | 2024-02-12 |
| I.T.S. INS Proximal Femur Nail (K233134) | I.T.S. GmbH | 2024-02-12 |
| Fine Osteotomy™ (K240066) | Bodycad Laboratories, Inc. | 2024-02-09 |
| V-STRUT® Vertebral Implant (K240084) | Hyprevention | 2024-02-09 |
| Z1 Hip System (K233476) | Orchard Medical Development | 2024-02-08 |
| INNOVERSE Spinal System (K233960) | Innosys Co., Ltd. | 2024-02-06 |
| Hawkeye Control Unit with Eyas Endoscope (K233115) | E Surgical, LLC | 2024-02-06 |
| MAGEC Spinal Bracing and Distraction System (K233593) | Nuvasive Specialized Orthopedics, Incorporated | 2024-02-06 |