# K100736: Kirschner and Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: Smt Schilling Metalltechnik GmbH
- Decided: Sep 10, 2010 after 179 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
Longest line of descent: 2 generations back to K961522 (1996). 3 ancestors in all.
65 later devices descend from it; 12 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030665: Bone Wire, Stork Instrumente GmbH (2003) Summary page 2.
- K070561: Kmedic Internal/External Fixation Devices, Teleflex Medical (2007) Summary page 2.

## Most influential descendants
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple (2012), 24 descendants of its own
- K131061: Restore Bunion Correction System (2013), 15 descendants of its own
- K131459: Aap K-Wire, Steinmann Pin, Cerclage Wire (2013), 12 descendants of its own
- K120787: Merete Locking Bone Plate System Iii (2012), 12 descendants of its own
- K133691: Extrimilock Ankle Plating System (2014), 10 descendants of its own

## Indications for use
Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.

Source page: https://510kreport.com/device/K100736
Methodology: https://510kreport.com/methodology