| Xpert Ankle (K261511) | Newclip Technics | 2026-07-28 |
| Versalock Proximal Tibial Plating System (K261406) | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) (K262032) | TriMed, Inc. | 2026-07-16 |
| Alians Elbow S (K261191) | Newclip Technics | 2026-07-08 |
| RibPlate System (K261054) | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| SALGINA 2.5mm Distal Radius System (K261351) | Bonebridge AG | 2026-06-26 |
| I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (K260958) | I.T.S. GmbH | 2026-06-16 |
| Exalta Proximal Tibia Plating System (K261207) | Tyber Medical, LLC | 2026-06-12 |
| APTUS Clavicle System 2.8 (K260761) | Medartis AG | 2026-06-05 |
| Pectus Blu System (K261002) | Biomet Microfixation | 2026-06-02 |
| Xpert PFP (K261038) | Newclip Technics | 2026-05-29 |
| Avanti Distal Elbow ORIF System (K261145) | Avanti Orthopaedics, LLC | 2026-05-09 |
| OrthoPediatrics® Locking Cannulated Blade Plate System (K260323) | OrthoPediatrics Corp. | 2026-04-30 |
| PC Fix System (K260411) | Chest Wall Innovations, Inc. | 2026-04-24 |
| I.T.S. PRS Phoenix II (K260054) | I.T.S. GmbH | 2026-04-24 |
| POYA 3.5mm Medial Proximal Tibia System (K260228) | Bonebridge AG | 2026-04-24 |
| SMART Osteotomy System (K260090) | Actis Medical Pty., Ltd. | 2026-04-10 |
| enHAnce PEEK Bunion System (K253718) | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| Airlock® Ankle Plating System (K260274) | Novastep SAS | 2026-03-25 |
| Vortex5 Tailor's Bunion Correction System (K260291) | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| LOQTEQ® VA Proximal Humerus Plate 3.5 (K254253) | Aap Implantate AG | 2026-03-24 |
| Clavicle Fixation System (K254288) | Skeletal Dynamics, Inc. | 2026-03-23 |
| CastleLoc Pectus Bar System (K260448) | L&K BIOMED Co., Ltd. | 2026-03-19 |
| APS Spear Locking Plate (K254053) | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
| Super Upper Limbs Versalock Plating System (K260390) | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (K253916) | Medartis AG | 2026-03-16 |
| Xpert Hand (K253906) | Newclip Technics | 2026-03-11 |
| DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (K254093) | Synthes GmbH | 2026-03-10 |
| DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069) | Synthes GmbH | 2026-03-09 |
| Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (K260353) | Arthrex, Inc. | 2026-03-03 |
| VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (K254054) | Synthes GmbH | 2026-03-02 |
| HKT Anatomical Locking Trauma System (K254249) | Hankil Tech Medical Co., Ltd. | 2026-02-27 |
| RIB LINK™ Fixation System (K252166) | Globus Medical, Inc. | 2026-02-26 |
| KLS Martin Pure Pectus System (K253660) | KLS-Martin L.P. | 2026-02-20 |
| KLS Martin Ixos System (K254162) | KLS Martin L.P. | 2026-02-20 |
| Wrist Fracture System (K251732) | Met One Technologies, LLC | 2026-02-12 |
| Arthrex Variable Angle (VA) Proximal Tibia Plating System (K253713) | Arthrex, Inc. | 2026-01-21 |
| TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) (K254002) | TriMed, Inc. | 2026-01-15 |
| Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (K252807) | Arthrex, Inc. | 2026-01-12 |
| TRILEAP Plating System (K253178) | Crossroads Extremity Systems | 2026-01-06 |
| Pectus Versa System (K251050) | Gm Dos Reis Industria E Comercio | 2025-12-19 |
| BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (K252191) | Bonebridge AG | 2025-12-17 |
| 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 |
| SternaFuse Ti Fixation System (K252661) | Fusion Innovations, LLC | 2025-11-19 |
| 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 |
| WRISTAR MultiAx Distal Radius Kit (K252959) | Intrauma S.P.A | 2025-11-12 |
| Fine Osteotomy™ (K253300) | Bodycad Laboratories, Inc. | 2025-10-28 |
| Pediatric Plating Platform I Small-Mini (K252600) | OrthoPediatrics Corp. | 2025-10-09 |
| MAXXOS P.A.C.E. Foot & Ankle Plating System (K251892) | Maxxos Medical GmbH | 2025-09-08 |
| 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 |
| Distal Xtremities System (K252061) | TriMed, Inc. | 2025-08-20 |
| ANTHEM® Fracture System (K251161) | Globus Medical, Inc. | 2025-08-18 |
| OsteoCentric® UnifiMI® TCS Plating System (K251913) | OsteoCentric Technologies | 2025-08-16 |
| KLS Martin Ixos System (K250620) | KLS Martin L.P. | 2025-08-15 |
| Tyber Medical Distal Radius Plating System (K251361) | Tyber Medical, LLC | 2025-07-30 |
| A.L.P.S. Proximal Humerus Plating System (K251620) | Zimmer Biomet | 2025-07-25 |
| Baby Gorilla®/Gorilla® Plating System (K250952) | Paragon 28, Inc. | 2025-07-18 |
| The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (K251132) | Acumed, LLC | 2025-07-14 |
| TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (K251945) | TriMed, Inc. | 2025-07-10 |
| Genostis Osteosynthesis System (K242988) | Genostis AF | 2025-06-27 |
| 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 |
| The Acumed Wrist Fixation System (K251296) | Acumed, LLC | 2025-06-18 |
| LORRAINE 2.5/3.5mm Distal Humerus System (K250933) | Bonebridge AG | 2025-06-11 |
| Montblanc Plate System (K243368) | Medifield Medical Co., Ltd. | 2025-06-04 |
| ARIX Pectus Bar System (K242751) | Jeil Medical Corporation | 2025-05-30 |
| SIGNEX (K243469) | Osteonic Co., Ltd. | 2025-05-29 |
| TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (K250935) | TriMed, Inc. | 2025-05-22 |
| Pediatric Plating Platform Hip (K243963) | OrthoPediatrics Corp. | 2025-04-29 |
| CastleLoc Pectus Bar System (K250892) | L&K BIOMED Co., Ltd. | 2025-04-25 |
| CanMINI Hand and Foot System (K242973) | Canwell Medical Co., Ltd. | 2025-04-24 |
| Xpert Knee (K250155) | Newclip Technics | 2025-04-23 |
| TriMed Fusion Cup System (K250948) | TriMed, Inc. | 2025-04-08 |
| Arthrex Humeral Plating System and Cerclage Button (K243995) | Arthrex, Inc. | 2025-03-26 |
| TriMed Ankle Fixation System (K243999) | TriMed, Inc. | 2025-03-19 |
| Tyber Medical Anatomical Plating System (K242486) | Tyber Medical, LLC | 2025-03-19 |
| TriMed Elbow and Forearm System (K243987) | TriMed, Inc. | 2025-03-19 |
| The OsteoCentric Bone Plate and Screw System (K250494) | OsteoCentric Technologies | 2025-03-18 |
| BPS Wrist Fracture System (K250498) | Orthonovis, Inc. | 2025-03-17 |
| APTUS Hand System; APTUS Elbow Dorsal Olecranon (K243610) | Medartis AG | 2025-03-07 |
| CastleLoc Pectus Bar System (K243357) | L&K BIOMED Co., Ltd. | 2025-02-27 |
| A.L.P.S. Small Fragment Plating System (K243761) | Biomet Orthopedics | 2025-02-19 |
| EVOS Pelvic and Acetabular System (K241666) | Smith & Nephew | 2025-02-19 |
| Locking Plates and Screws Systems (K240958) | Hebei Ruihe Medical Devices Co., Ltd. | 2025-02-10 |
| Signature Osteosynthesis Plate System (K241599) | Signature Orthopaedic Pty , Ltd. | 2025-02-06 |
| BPS - Bone Fragment Fixation Plates, Screws and Washers (K250055) | Orthonovis, Inc. | 2025-02-06 |
| Versalock Upper Limb Plating System (K243740) | GM Dos Reis Industria e Comercio Ltda. | 2025-01-29 |
| TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); (K243569) | TriMed, Inc. | 2025-01-15 |
| ARTFX Trauma Bone Plate and Screw System (K242939) | Artfx Medical | 2024-12-23 |
| Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (K243308) | Bonebridge AG | 2024-12-20 |
| SternalPlate Expansion (K243491) | Stryker Leibinger GmbH & Co KG | 2024-12-11 |
| TDM Plate and Screw System (K241128) | Tdm Co., Ltd. | 2024-12-05 |
| HyperFlex™ Bunion Correction System (K241995) | Footbridge Medical | 2024-11-26 |
| TriMed Posterior Malleolus Fixation System (K243050) | TriMed, Inc. | 2024-11-26 |