# K982931: Threaded Fixation Pin

- Pathway: 510(k) (Traditional)
- Applicant: Sgarlato Laboratories, Inc.
- Decided: Oct 21, 1998 after 62 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Orthopaedic Biosystems Limited Threaded Fixation Pin: named in the summary without a submission number
- (no number) Synthes Threaded Kirschner Wires: named in the summary without a submission number

## Most influential descendants
- K011875: Modification to the Tac' Pin (2001), 0 descendants of its own

## Indications for use
The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.

Source page: https://510kreport.com/device/K982931
Methodology: https://510kreport.com/methodology