FDA Product Code
FDA Product Code HRS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 1,329 records · page 2 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. | 2025-02-06 | Special | PDF ↗ |
| K243740 | Versalock Upper Limb Plating System | GM Dos Reis Industria e Comercio Ltda. | 2025-01-29 | Traditional | PDF ↗ |
| K243569 | 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); | TriMed, Inc. | 2025-01-15 | Traditional | PDF ↗ |
| K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024-12-23 | Traditional | PDF ↗ |
| K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | Bonebridge AG | 2024-12-20 | Traditional | PDF ↗ |
| K243491 | SternalPlate Expansion | Stryker Leibinger GmbH & Co KG | 2024-12-11 | Special | PDF ↗ |
| K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | 2024-12-05 | Special | PDF ↗ |
| K241995 | HyperFlex Bunion Correction System | Footbridge Medical | 2024-11-26 | Traditional | PDF ↗ |
| K243050 | TriMed Posterior Malleolus Fixation System | TriMed, Inc. | 2024-11-26 | Traditional | PDF ↗ |
| K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-21 | Traditional | PDF ↗ |
| K242998 | GMReis Ankle Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-21 | Traditional | PDF ↗ |
| K242436 | Proximal Humerus Fixation System | Skeletal Dynamics, Inc. | 2024-11-14 | Traditional | PDF ↗ |
| K242079 | Arthrex Elbow Fracture Plating System | Arthrex, Inc. | 2024-11-14 | Traditional | PDF ↗ |
| K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. | 2024-11-14 | Traditional | PDF ↗ |
| K240388 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2024-11-01 | Traditional | PDF ↗ |
| K242399 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2024-10-31 | Traditional | PDF ↗ |
| K242995 | OIC Small / Mini Fragment Plate System | The Orthopaedic Implant Company | 2024-10-23 | Special | PDF ↗ |
| K242554 | Arthrex VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | 2024-10-21 | Traditional | PDF ↗ |
| K240181 | Clavicle and Scapula System | Auxein Medical Pvt., Ltd. | 2024-10-09 | Traditional | PDF ↗ |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | Stryker GmbH | 2024-10-06 | Traditional | PDF ↗ |
| K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024-10-04 | Traditional | PDF ↗ |
| K241815 | Protean Fragment Plating System | Skeletal Dynamics, Inc. | 2024-09-26 | Traditional | PDF ↗ |
| K241709 | Pectus Blu Support Bar System | Biomet Microfixation | 2024-09-19 | Traditional | PDF ↗ |
| K241942 | TriMed Bridge Plates | TriMed, Inc. | 2024-09-17 | Traditional | PDF ↗ |
| K241356 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2024-09-05 | Traditional | PDF ↗ |
| K240487 | EVOS Patella Plates | Smith & Nephew | 2024-09-03 | Traditional | PDF ↗ |
| K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024-08-28 | Traditional | PDF ↗ |
| K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | 2024-08-23 | Traditional | PDF ↗ |
| K241282 | RibFix Titan Fixation System | Riverpoint Medical | 2024-08-19 | Traditional | PDF ↗ |
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate | Zimmer Switzerland Manufacturing GmbH | 2024-08-15 | Traditional | PDF ↗ |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | In2bones USA | 2024-08-13 | Traditional | PDF ↗ |
| K242055 | Freefix Forearm Plating System | Skeletal Dynamics, Inc. | 2024-08-01 | Special | PDF ↗ |
| K241539 | Activmotion S | Newclip Technics | 2024-07-30 | Traditional | PDF ↗ |
| K233994 | VOLT Proximal Humerus 3.5 Plating System | Synthes GmbH | 2024-07-26 | Traditional | PDF ↗ |
| K241296 | Gaudi Proximal Humerus Plate | Netbiologics, LLC | 2024-07-23 | Traditional | PDF ↗ |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | 2024-07-12 | Traditional | PDF ↗ |
| K232829 | Versalock Rib and Sternum Plates System | GM Dos Reis Industria e Comercio Ltda. | 2024-06-26 | Traditional | PDF ↗ |
| K234059 | Forma Medical Optimal Plating System | Forma Medical, Inc. | 2024-06-26 | Traditional | PDF ↗ |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | Medartis AG | 2024-06-20 | Traditional | PDF ↗ |
| K230546 | SIGNEX | Osteonic Co., Ltd. | 2024-06-11 | Traditional | PDF ↗ |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024-06-05 | Special | PDF ↗ |
| K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024-05-31 | Special | PDF ↗ |
| K233089 | NeoSpan® Compression Implant System | In2bones USA, LLC | 2024-05-24 | Traditional | PDF ↗ |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH | 2024-05-09 | Traditional | PDF ↗ |
| K233873 | XLO Brand of Locking Distal Humerus Plating System | Ortho Life Systems Private Limited | 2024-04-26 | Traditional | PDF ↗ |
| K233311 | Acumed Wrist Plating System | Acumed, LLC | 2024-04-22 | Traditional | PDF ↗ |
| K232105 | APTUS Foot System 2.8-3.5 | Medartis AG | 2024-04-19 | Traditional | PDF ↗ |
| K233863 | 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- | TriMed, Inc. | 2024-04-17 | Traditional | PDF ↗ |
| K240703 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2024-04-12 | Special | PDF ↗ |
| K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024-04-05 | Traditional | PDF ↗ |
| K233919 | VariAx 2 Distal Radius System | Stryker GmbH | 2024-03-25 | Traditional | PDF ↗ |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | DePuy Synthes | 2024-03-21 | Traditional | PDF ↗ |
| K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024-03-21 | Traditional | PDF ↗ |
| K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024-02-22 | Special | PDF ↗ |
| K231213 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | 2024-01-19 | Traditional | PDF ↗ |
| K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP | 2024-01-18 | Special | PDF ↗ |
| K231684 | Quick - Radius Disposable Set | GM Dos Reis Industria e Comercio Ltda. | 2024-01-12 | Special | PDF ↗ |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System | Tyber Medical, LLC | 2023-12-21 | Traditional | PDF ↗ |
| K233154 | SkyOPS Orthopedic Plate System | Sky Surgical, LLC | 2023-12-21 | Traditional | PDF ↗ |
| K233017 | TM Plating System | Tyber Medical, LLC | 2023-12-20 | Traditional | PDF ↗ |
| K232394 | Internal Locking Plate and Screw Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023-12-15 | Traditional | PDF ↗ |
| K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023-12-14 | Traditional | PDF ↗ |
| K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023-12-13 | Traditional | PDF ↗ |
| K232515 | Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | 2023-12-08 | Traditional | PDF ↗ |
| K232693 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | 2023-12-04 | Traditional | PDF ↗ |
| K230591 | TriLEAP Plating System | Crossroads Extremity Systems | 2023-09-29 | Traditional | PDF ↗ |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | 2023-09-25 | Traditional | PDF ↗ |
| K230623 | KITE Distal Fibula Kit | Intrauma S.P.A | 2023-09-01 | Traditional | PDF ↗ |
| K230805 | TriMed Clavicle Fixation System | TriMed, Inc. | 2023-09-01 | Traditional | PDF ↗ |
| K231623 | Distal Elbow Plating System | Skeletal Dynamics, Inc. | 2023-08-28 | Traditional | PDF ↗ |
| K223150 | APS Metal Plate & Screw System | A Plus Biotechnology Co., Ltd. | 2023-08-24 | Traditional | PDF ↗ |
| K232144 | Sterile Products of the APTUS System | Medartis AG | 2023-08-18 | Special | PDF ↗ |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Stryker GmbH | 2023-08-18 | Traditional | PDF ↗ |
| K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023-08-18 | Traditional | PDF ↗ |
| K230690 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2023-08-17 | Traditional | PDF ↗ |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | Bonebridge AG | 2023-07-19 | Traditional | PDF ↗ |
| K231441 | ARIX Ankle System | Jeil Medical Corporation | 2023-07-17 | Traditional | PDF ↗ |
| K230971 | APTUS® 3.5 TriLock Straight Plates | Medartis AG | 2023-06-02 | Traditional | PDF ↗ |
| K223762 | Smith & Nephew ACCORD Cable System | Smith & Nephew | 2023-05-30 | Traditional | PDF ↗ |
| K222624 | KLS Martin LINOS Wrist System | KLS-Martin L.P. | 2023-05-25 | Traditional | PDF ↗ |
| K230938 | ARIX Humerus System | Jeil Medical Corporation | 2023-05-03 | Special | PDF ↗ |
| K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Stryker GmbH | 2023-04-27 | Traditional | PDF ↗ |
| K230204 | ALPHALOK Plating System | Vilex, LLC | 2023-04-25 | Traditional | PDF ↗ |
| K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | Stryker GmbH | 2023-04-07 | Traditional | PDF ↗ |
| K223342 | MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System | Crossroads Extremity Systems, LLC | 2023-03-30 | Traditional | PDF ↗ |
| K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023-03-30 | Traditional | PDF ↗ |
| K222397 | KLS Martin Level One Rib Fixation System | KLS-Martin L.P. | 2023-03-29 | Traditional | PDF ↗ |
| K230527 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2023-03-29 | Special | PDF ↗ |
| K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | 2023-03-28 | Traditional | PDF ↗ |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | Aap Implantate AG | 2023-03-17 | Traditional | PDF ↗ |
| K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023-03-07 | Traditional | PDF ↗ |
| K213059 | Tibia and Fibula System | Auxein Medical Private Limited | 2023-01-27 | Traditional | PDF ↗ |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Medline Industries, Inc. | 2023-01-25 | Traditional | PDF ↗ |
| K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023-01-25 | Traditional | PDF ↗ |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | Orthopaedic Implant Company | 2023-01-21 | Traditional | PDF ↗ |
| K221088 | Anatomic Bone Plate | Double Medical Technology, Inc. | 2023-01-18 | Traditional | PDF ↗ |
| K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023-01-05 | Traditional | PDF ↗ |
| K222637 | TriMed Wrist Fixation System 3 | TriMed, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K221412 | ARIX Rib System | Jeil Medical Corporation | 2022-11-22 | Traditional | PDF ↗ |
| K221558 | ALPHALOK Plating System | Vilex, LLC | 2022-11-15 | Traditional | PDF ↗ |
Product code HRS · Class II · Orthopedic. Data: openFDA.