# K143385: Acumed Ankle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Apr 6, 2015 after 131 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: 13 generations back to K962616 (1996). 97 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 121 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 4.
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 4.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.

## Most influential descendants
- K151886: Acumed Ankle and Small Fragment Base Set Update (2015), 15 descendants of its own
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own
- K191535: CoLink® Mini Plating System (2019), 6 descendants of its own
- K212487: CoLink Vallux Plating System (2021), 4 descendants of its own
- K211650: The Radian MIS Bunion System (2021), 3 descendants of its own

## Indications for use
The Acumed Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K143385
Methodology: https://510kreport.com/methodology