# K230908: Hand Trauma Threaded Nail System

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Apr 28, 2023 after 28 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 5 generations back to K030302 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220723: Hand Trauma Screw System, Skeletal Dynamics, Inc. (2022) Summary page 4.

## Indications for use
The Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.

Source page: https://510kreport.com/device/K230908
Methodology: https://510kreport.com/methodology