# K971272: Trauma-Fix External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Trend Medical, Inc.
- Decided: Jun 5, 1997 after 62 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OrthoFrame™: named in the summary without a submission number
- (no number) Hoffman-Type External Fixation: named in the summary without a submission number
- (no number) ACE-Fischer™ Fixator: named in the summary without a submission number
- (no number) ACE-Align Fixator™: named in the summary without a submission number

## Most influential descendants
- K182285: PK High Tibial Osteotomy Correction System (2019), 0 descendants of its own

## Indications for use
External fixation of long bone fractures. External fixation and stabilization of surgical osteotomy sites. Leg lengthening procedures. Knee, hip and ankle arthrodesis. External fixation of septic and aseptic non-union of long bones Pelvic fixation

Source page: https://510kreport.com/device/K971272
Methodology: https://510kreport.com/methodology