# K250646: Impact PEEK Union Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies
- Decided: Jun 11, 2025 after 99 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: 4 generations back to K901456 (1990). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133932: Inion Freedompin, Inion OY (2014) Summary page 6.
- K181180: OSSIO™ Pin Product Family, OSSIO, Ltd. (2019) Summary page 6.

## Most influential descendants
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own
- K252657: Impact PEEK Union Nail System (2025), 0 descendants of its own

## Indications for use
The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Source page: https://510kreport.com/device/K250646
Methodology: https://510kreport.com/methodology