# K211628: MIS Precision Chevron Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Relja Innovations, LLC
- Decided: Jan 31, 2022 after 249 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 3 generations back to K792022 (1979). 9 ancestors in all.
1 later device descends from it; 1 cites 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)
- K070039: Memometal Fixos Screws, Memometal Technologies (2007) Summary page 4.

## Most influential descendants
- K262075: Lapidus Screw Kit (2026), 0 descendants of its own

## Indications for use
The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

Source page: https://510kreport.com/device/K211628
Methodology: https://510kreport.com/methodology