# K970036: Fixation Pin or Rod

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Mar 25, 1997 after 81 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 K953194 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953194: Lactosorb Bone Pin, Biomet, Inc. (1995) Summary page 1.

## Indications for use
The Surgical Dynamics™ Bone Pin** is a resorbable fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization.

Source page: https://510kreport.com/device/K970036
Methodology: https://510kreport.com/methodology