# K152454: HemiCAP MTP Resurfacing Hemi-Arthroplasty System

- Pathway: 510(k) (Special)
- Applicant: Arthrosurface, Inc.
- Decided: Apr 11, 2016 after 227 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: 8 generations back to K864492 (1987). 24 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 31 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 5.
- K131377: Hemicap MTP Resurfacing Hemi-Arthroplasty Implant, Arthrosurface, Inc. (2013) Summary page 5.
- K132496: Arthrosurface Toemotion, Arthrosurface, Inc. (2014) Summary page 5.

## Most influential descendants
- K190543: Cannulated Hemi Implant (2019), 5 descendants of its own
- K203634: BioPoly Great Toe Hemiarthroplasty Implant (2021), 2 descendants of its own
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (2022), 1 descendant of its own
- K200951: Accu-Joint Hemi Implant (2020), 1 descendant of its own
- K233592: BioPoly Radial Head Implant (2024), 0 descendants of its own

## Indications for use
Hemi-Arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Source page: https://510kreport.com/device/K152454
Methodology: https://510kreport.com/methodology