# K945670: Kirschner (K-Wire), Steinman Pins

- Pathway: 510(k) (Traditional)
- Applicant: Brasseler USA I, L.P.
- Decided: Mar 7, 1995 after 109 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 28, 2022 · Class II · Z-0707-2022: One lot of product was distributed in unsealed packaging
- Dec 11, 2019 · Class II · Z-0884-2020: 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly l

Source page: https://510kreport.com/device/K945670
Methodology: https://510kreport.com/methodology