# K132496: Arthrosurface Toemotion

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Feb 26, 2014 after 201 days
- Product code: LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained)
- Device class: U
- 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: 3 generations back to K920446 (1993). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102549: The Ascension Movement Great Toe System Total Arthroplasty, Ascension Orthopedics, Inc. (2010) Summary page 2.
- K072251: Merete Toemobile Anatomical Great Toe Resurfacing System, Merete Medical GmbH (2008) Summary page 2.

## Most influential descendants
- K152454: HemiCAP MTP Resurfacing Hemi-Arthroplasty System (2016), 6 descendants of its own
- 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

## Recalls of this device
- Jun 9, 2014 · Class II · Z-0475-2016: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

## Indications for use
The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only. Indications for use include: * Painful degenerative metatarso-phalangeal joint change * Hallus rigidus stage 3 and 4 * Hallux valgus and hallux rigidus * Hallux limitus with painful arthrofibrosis * Revisions after moderate proximal phalanx resection

Source page: https://510kreport.com/device/K132496
Methodology: https://510kreport.com/methodology