# K072922: 3S Hemi Toe

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Nov 28, 2007 after 44 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: 2 generations back to K864492 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971047: Futura Biomedical Metal Hemi Toe Implant, Nexa Orthopedics, Inc. (1997) Summary page 1.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 1.
- K911378: Townley Great Toe Joint, Biopro, Inc. (1991) Summary page 1.

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1611-2020: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

## Indications for use
The 3S Hemi Toe Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.

Source page: https://510kreport.com/device/K072922
Methodology: https://510kreport.com/methodology