# K250074: HYALEX® MTP Hemiarthroplasty Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hyalex Orthopaedics, Inc.
- Decided: Apr 3, 2026 after 448 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K864492 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131377: Hemicap MTP Resurfacing Hemi-Arthroplasty Implant, Arthrosurface, Inc. (2013) Summary page 5.

## Indications for use
The HYALEX® MTP Hemiarthroplasty Implant is intended to be implanted to replace the distal metatarsal surface of the great toe for treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus, hallux limitus, or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is intended for single use and for use without bone cement.

Source page: https://510kreport.com/device/K250074
Methodology: https://510kreport.com/methodology