# K082017: Starr Frame Steinmann Pin

- Pathway: 510(k) (Abbreviated)
- Applicant: Starr Frame, LLC
- Decided: Oct 10, 2008 after 86 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 K960385 (1996). 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)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 1.
- K070561: Kmedic Internal/External Fixation Devices, Teleflex Medical (2007) Summary page 1.
- (no number) Depuy Steinmann Pins (Pre-amendment): named in the summary without a submission number

## Indications for use
The Starr Frame Steinmann Pins are non-sterile, single use, fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K082017
Methodology: https://510kreport.com/methodology