# K201393: restor3d MTP Implant

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D, Inc.
- Decided: May 25, 2022 after 728 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864492 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090127: Metatarsal Decompression Implant, Model 100, Solana Surgical, LLC (2009) Summary page 4.

## Recalls of this device
- Sep 4, 2026 · Class II · Z-0264-2027: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

## Indications for use
The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.

Source page: https://510kreport.com/device/K201393
Methodology: https://510kreport.com/methodology