# K252657: Impact PEEK Union Nail System

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Sep 19, 2025 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: 7 generations back to K792022 (1979). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250646: Impact PEEK Union Nail System, Nvision Biomedical Technologies (2025) Summary page 6.
- K143618: Kirschner Wires, Steinmann Pins, Zimmer, Inc. (2015) Summary page 6.
- K160304: OsteoBullet Compression Screw, Phalanx Innovations (2016) Summary page 6.

## 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/K252657
Methodology: https://510kreport.com/methodology