# K241995: HyperFlex™ Bunion Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Footbridge Medical
- Decided: Nov 26, 2024 after 140 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: 10 generations back to K792022 (1979). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090107: Mini Tightrope, Arthrex, Inc. (2009) Summary page 5.

## Most influential descendants
- K252997: HyperFlex® Bunion Correction System (2025), 0 descendants of its own

## Indications for use
The FootBridge Medical HyperFlexTM 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/K241995
Methodology: https://510kreport.com/methodology