# K092047: Ascension Metal Great Toe System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Jan 14, 2010 after 192 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K221220: Montross Extremity Medical Hemi Implant System (2023), 0 descendants of its own

## Indications for use
The Ascension® Metal Great Toe, System consists of a metatarsal component and a phalangeal component designed for resurfacing the Ist metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemi-arthmoplasties as an uncemented 'joint treatment of patients With arthritis in the flrst metatarsal joint in the presence of good bone stock. Indications include: * Hallux valgus; or Hailux Jimitus * Hallux rigidlus * Unstable or painful metatarsal/phalangeal (MTP) joint

Source page: https://510kreport.com/device/K092047
Methodology: https://510kreport.com/methodology