# K961522: Kirschner Wire (K-Wire) and Steinmann Pin

- Pathway: 510(k) (Traditional)
- Applicant: Synvasive Technology, Inc.
- Decided: Sep 23, 1996 after 154 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.
439 later devices descend from it; 3 cite it directly.
0 of 440 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) DePuy K-Wires and Steinmann Pins: named in the summary without a submission number
- (no number) Howmedica K-Wires and Steinmann Pins: named in the summary without a submission number
- (no number) MicroAire K-Wires and Steinmann Pins: named in the summary without a submission number
- (no number) Zimmer K-Wires and Steinmann Pins: named in the summary without a submission number

## Most influential descendants
- K990156: Multitak SS Buttons (1999), 336 descendants of its own
- K033717: Transet Fracture Fixation System (2004), 309 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own

## Indications for use
The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

Source page: https://510kreport.com/device/K961522
Methodology: https://510kreport.com/methodology