# K063058: Arthrex Anatoemic Phalangeal Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 3, 2007 after 90 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: 3 generations back to K864492 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant, Arthrosurface, Inc. (2004) Summary page 1.
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Biopro, Inc. (2004) Summary page 1.

## Indications for use
The Arthrex AnaToemicTM Phalangeal Prosthesis is a press-fit implant that is intended to be used in patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, rheumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.

Source page: https://510kreport.com/device/K063058
Methodology: https://510kreport.com/methodology