# K252997: HyperFlex® Bunion Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Hyperflex Medical
- Decided: Dec 11, 2025 after 84 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: 11 generations back to K792022 (1979). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241995: HyperFlex™ Bunion Correction System, Footbridge Medical (2024) Summary page 5.

## Indications for use
The HyperFlex® Medical HyperFlex® Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal-2nd metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ~13 years in which growth plates have fused.

Source page: https://510kreport.com/device/K252997
Methodology: https://510kreport.com/methodology