# K221220: Montross Extremity Medical Hemi Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Montross Extremity Medical
- Decided: Apr 19, 2023 after 357 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: 4 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)
- K092047: Ascension Metal Great Toe System, Ascension Orthopedics, Inc. (2010) Summary page 4.
- K971047: Futura Biomedical Metal Hemi Toe Implant, Nexa Orthopedics, Inc. (1997) Summary page 4.

## Indications for use
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include: - Hallux valgus or Hallux limitus - Hallux rigidus - Unstable or painful metatarsallphalangeal (MTP) joint

Source page: https://510kreport.com/device/K221220
Methodology: https://510kreport.com/methodology