# K030665: Bone Wire

- Pathway: 510(k) (Traditional)
- Applicant: Stork Instrumente GmbH
- Decided: Mar 25, 2003 after 22 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: 1 generation back to K961522 (1996). 1 ancestor in all.
113 later devices descend from it; 3 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961522: Kirschner Wire (K-Wire) and Steinmann Pin, Synvasive Technology, Inc. (1996) Summary page 2.

## Cited in the summary but kept off the family tree
- K083121: Neo Mapcath Sensor Stylet, Corpak Medsystems (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K071862: Bone Wires (Steinmann Pins), Osteonics Corporation. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K060385: Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent, Dade Behring, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K100736: Kirschner and Guide Wires (2010), 65 descendants of its own
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins (2009), 48 descendants of its own
- 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

## Indications for use
The intended use of Stork lnstrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system. Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants. Stork lnstrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process. Stork lnstrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270"F, 3 bar, for 10 minutes.

Source page: https://510kreport.com/device/K030665
Methodology: https://510kreport.com/methodology