510(k) · Cleared
Recalled · Class II · 2014Arthrosurface Toemotion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Cleared on Feb 26, 2014 as substantially equivalent to K102549 (Ascension Orthopedics, Inc., 2010) and 1 other predicate after a 201-day review. Its family tree reaches back 3 generations to 1993. 7 later devices descend from it. It has been recalled once.
- Decided
- Feb 26, 2014
- Review
- 201 days
- Class
- Class U
- Product code
- LZJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920446 (1993). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK920446 Total Toe SystemBiomet, Inc. · 1993
- 2 generations backK072251 Merete Toemobile Anatomical Great Toe Resurfacing SystemMerete Medical GmbH · 2008
- 1 generation backK102549 The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 2010
- This deviceK132496 Arthrosurface ToemotionArthrosurface, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK222964 BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK200951 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016 · cites it directly6descendants
- K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019 · cites it directly5descendants
- K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021 · 2 generations on2descendants
- K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022 · 2 generations on1descendant
- K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920446 | Total Toe System | Biomet, Inc. | 1993 | — |
| −2 | K072251 | Merete Toemobile Anatomical Great Toe Resurfacing System | Merete Medical GmbH | 2008 | — |
| −1 | K102549 | The Ascension Movement Great Toe System Total Arthroplasty | Ascension Orthopedics, Inc. | 2010 | — |
| 0 (this device) | K132496 | Arthrosurface Toemotion | Arthrosurface, Inc. | 2014 | — |
| +1 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| +1 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| +2 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
| +2 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022 | — |
| +2 | K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102549 | The Ascension Movement Great Toe System Total ArthroplastySummary page 2…stantially equivalent to the following previously cleared and commercially marketed devices: * Ascension MOVEMENT Great Toe System K102549 * Merete ToeMobile Anatomical Great Toe Resurfacing System K072251 The fundamental scientific technology of the… | 2010 |
| * | K072251 | Merete Toemobile Anatomical Great Toe Resurfacing SystemSummary page 2…devices: * Ascension MOVEMENT Great Toe System K102549 * Merete ToeMobile Anatomical Great Toe Resurfacing System K072251 The fundamental scientific technology of the proposed device has not changed relative to the predicate devices. " Total ar… | 2008 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2014 | Class II | Z-0475-2016 | Process change control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152454 (Arthrosurface, Inc., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LZJ devicesLZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZJ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LZJ
Too few LZJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LZJ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZJ
1in 2024
MAUDE reports naming product code LZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132496: Arthrosurface Toemotion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132496
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026