# K243999: TriMed Ankle Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Mar 19, 2025 after 83 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: 14 generations back to K962616 (1996). 101 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 5.
- K010545: TBW, Tri-Med, Inc. (2001) Summary page 5.
- K143385: Acumed Ankle Plating System, Acumed, LLC (2015) Summary page 5.

## Most influential descendants
- K251945: TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (2025), 1 descendant of its own
- K262032: TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) (2026), 0 descendants of its own

## Indications for use
The TriMed Sidewinder and Cluster Plates are indicated for fractures, non-unions & osteotomies of the distal fibula. The TriMed Straight Plates and Ankle Hook Plates are indicated for fractures, non-unions & osteotomies of the distal fibula and distal tibia. The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.

Source page: https://510kreport.com/device/K243999
Methodology: https://510kreport.com/methodology