# K250613: SnapHammer Hammertoe Correction System

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Apr 2, 2025 after 33 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: 13 generations back to K792022 (1979). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231453: SnapHammer Hammertoe Correction System, Nvision Biomedical Technologies, Inc. (2024) Summary page 6.

## Indications for use
The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

Source page: https://510kreport.com/device/K250613
Methodology: https://510kreport.com/methodology