# K262075: Lapidus Screw Kit

- Pathway: 510(k) (Special)
- Applicant: Relja Innovations, LLC
- Decided: Jul 22, 2026 after 30 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: 4 generations back to K792022 (1979). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211628: MIS Precision Chevron Bunion System, Relja Innovations, LLC (2022) Summary page 6.
- K133451: Fixos Screw System, Stryker Trauma AG (2014) Summary page 6.

## Indications for use
The Lapidus Screw Kit is intended for use in first tarsometatarsal (Lapidus) arthrodesis and elective osteotomies involving the midfoot, metatarsals, and phalanges of the foot.

Source page: https://510kreport.com/device/K262075
Methodology: https://510kreport.com/methodology