# K971962: Osteo Kirschner Wires

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Aug 11, 1997 after 75 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Osteo Kirschner Wires (Osteo AG): named in the summary without a submission number
- (no number) Kirschner Wires (Smith + Nephew Richards): named in the summary without a submission number
- (no number) Kirschner Wires (Synthes): named in the summary without a submission number

## Most influential descendants
- K211508: Steinmann Pins and Kirschner Wires (2021), 0 descendants of its own
- K092002: Afghan External Fixator (2009), 0 descendants of its own

## Indications for use
Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small-bone fractures. For use as guide wires in hip pinning procedures, For use in aligning and reducing long bone fractures, For use in securing non-long bone fractures such as olecranon fractures; patella fractures; tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc. For use with cerclage wire/cable in treating greater trochanter fractures.

Source page: https://510kreport.com/device/K971962
Methodology: https://510kreport.com/methodology