# K253718: enHAnce PEEK Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Apr 1, 2026 after 128 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K962616 (1996). 241 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211650: The Radian MIS Bunion System, Nvision Biomedical Technologies, Inc. (2021) Summary page 5.
- K192356: Airlock Centrolock Osteosynthesis Implant System, Novastep (2019) Summary page 5.
- K190658: MIS Bunion Plating System, Crossroads Extremity Systems, LLC (2019) Summary page 5.
- K250646: Impact PEEK Union Nail System, Nvision Biomedical Technologies (2025) Summary page 5.
- K241014: Biomet Kirschner Wires (K-Wires), Biomet, Inc. (2024) Summary page 5.

## Most influential descendants
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own

## Indications for use
The enHAnce PEEK Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

Source page: https://510kreport.com/device/K253718
Methodology: https://510kreport.com/methodology