# K031334: Texas T - Plate

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 22, 2003 after 24 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: 1 generation back to K962616 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962616: Synthes Dorsal Distal Radius Plate (DDRP) System, Synthes (Usa) (1996) Summary page 1.
- K020221: Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Indications for use
The Texas T - Plate Distal Radius Plating System is indicated for use in open reduction and internal fixation of fresh fractures, osteotomies, arthrodesis, and revision procedures of the distal radius.

Source page: https://510kreport.com/device/K031334
Methodology: https://510kreport.com/methodology