# K073635: Sbi SR MTP Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Mar 19, 2008 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The SBi SR MTP Toe Implant is intended for nse as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.

Source page: https://510kreport.com/device/K073635
Methodology: https://510kreport.com/methodology