# K151732: Arthrex Fracture Plates - Pathway: 510(k) (Special) - Applicant: Arthrex, Inc. - Decided: Aug 28, 2015 after 63 days - Product code: HRS (Plate, Fixation, Bone) - Device class: 2 - Regulation: 21 CFR 888.3030 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 11 generations back to K000684 (2000). 76 ancestors in all. 21 later devices descend from it; 4 cite it directly. 0 of 98 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 4. - K141478: Arthrex Fracture Plates and Screws, Arthrex, Inc. (2014) Summary page 4. ## Most influential descendants - K201132: Arthrex Compression Screws (2020), 11 descendants of its own - K171808: TDM Plate and Screw System (2018), 6 descendants of its own - K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own - K203294: Arthrex Pilon Fusion System (2021), 2 descendants of its own - K254215: Arthrex Beaming System (2026), 1 descendant of its own ## Indications for use The Arthrex Fracture Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula. The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates. Source page: https://510kreport.com/device/K151732 Methodology: https://510kreport.com/methodology