# K122936: Ankle Trauma System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopro, LLC
- Decided: Feb 28, 2013 after 157 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: 2 generations back to K000684 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 2.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 1.

## Most influential descendants
- K133541: Emerge Medical Small and Large Non-Locking Fragment Plate System (2014), 0 descendants of its own

## Indications for use
The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and nan-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.

Source page: https://510kreport.com/device/K122936
Methodology: https://510kreport.com/methodology