# K211508: Steinmann Pins and Kirschner Wires

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Oct 5, 2021 after 144 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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 K971962 (1997). 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)
- K001886: Apex Fixation Pins, Howmedica Osteonics Corp. (2000) Summary page 5.
- K971962: Osteo Kirschner Wires, Osteonics Corp. (1997) Summary page 5.

## Indications for use
The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation. The 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 temporary stabilization of bone fractures such as olecranon fractures; patella fractures; tibia plateau fractures; hand and foot bone fractures; humeral, radial and ulnar fractures. » For use with cerclage wire/cable in treating greater trochanter fractures.

Source page: https://510kreport.com/device/K211508
Methodology: https://510kreport.com/methodology