# K123241: Arthrex Fracture Plates

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 5, 2013 after 170 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: 9 generations back to K000684 (2000). 74 ancestors in all.
71 later devices descend from it; 14 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 2.
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 2.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011)
- K112437: Arthrex Fracture System, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K141735: Arthrex Ankle Fusion Plating System (2014), 38 descendants of its own
- K141478: Arthrex Fracture Plates and Screws (2014), 23 descendants of its own
- K151732: Arthrex Fracture Plates (2015), 21 descendants of its own
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own
- K201132: Arthrex Compression Screws (2020), 11 descendants 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, fibula. The Arthrex Low Profile Screws (2.0-2.4mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates. The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. 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. The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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.

Source page: https://510kreport.com/device/K123241
Methodology: https://510kreport.com/methodology