# K143139: Arthrex Fracture System

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jan 16, 2015 after 74 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). 73 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112437: Arthrex Fracture System, Arthrex, Inc. (2011) Summary page 4.

## Most influential descendants
- K203239: Arthrex Low Profile Screws (2020), 0 descendants of its own

## Indications for use
The Arthrex Fracture System is 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, femur, and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws. The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.

Source page: https://510kreport.com/device/K143139
Methodology: https://510kreport.com/methodology