# K062040: Sbi Trihedron MTP Hemi GT

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Oct 3, 2006 after 76 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 Trihedron MTP Hemi Great Toe is intended as a resurfacing implant for the metatarso-phalangeal joint for: 1. Arthritic degeneration of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of normal ambulatory function of the forefoot. 2. Degenerative arthritis 3. Rheumatoid arthritis 4. Bunion deformity associated with arthritis of the metatarso-phalangeal joint

Source page: https://510kreport.com/device/K062040
Methodology: https://510kreport.com/methodology