# K262722: Primal K-Wire (P99-193-1410)

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Aug 28, 2026 after 28 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: 5 generations back to K961522 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171715: HammerTube System, Paragon 28 (2018) Summary page 5.

## Indications for use
The Primal K-Wire implant is indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation for the foot.

Source page: https://510kreport.com/device/K262722
Methodology: https://510kreport.com/methodology