# K010545: TBW

- Pathway: 510(k) (Traditional)
- Applicant: Tri-Med, Inc.
- Decided: Jun 6, 2001 after 103 days
- Product code: NDL (Pin, Fixation, Smooth, Metallic)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K951303 (1995). 1 ancestor in all.
10 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951303: SFC, Medpac (1995) Summary page 2.

## Most influential descendants
- K222637: TriMed Wrist Fixation System 3 (2022), 3 descendants of its own
- K243999: TriMed Ankle Fixation System (2025), 2 descendants of its own
- K251945: TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (2025), 1 descendant of its own
- K243987: TriMed Elbow and Forearm System (2025), 1 descendant of its own
- K262649: Alians Forearm (2026), 0 descendants of its own

## Indications for use
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecration, patella, medial malleolus, lateral malloolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury.

Source page: https://510kreport.com/device/K010545
Methodology: https://510kreport.com/methodology