510(k) · Cleared
ClearedMerete Toemobile Anatomical Great Toe Resurfacing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Cleared on May 8, 2008 as substantially equivalent to K920446 (Biomet, Inc., 1993) and 1 other predicate after a 269-day review. Its family tree reaches back 1 generation to 1993. 9 later devices descend from it.
- Decided
- May 8, 2008
- Review
- 269 days
- Class
- Class U
- Product code
- LZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920446 (1993). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920446 Total Toe SystemBiomet, Inc. · 1993
- This deviceK072251 Merete Toemobile Anatomical Great Toe Resurfacing SystemMerete Medical GmbH · 2008
- Descendant · cites it directly · 8 of its ownK102549 The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK132496 Arthrosurface ToemotionArthrosurface, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 6 of its ownK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K102549The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 2010 · cites it directly8descendants
- K132496Arthrosurface ToemotionArthrosurface, Inc. · 2014 · cites it directly7descendants
- K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016 · 2 generations on6descendants
- K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019 · 2 generations on5descendants
- K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920446 | Total Toe System | Biomet, Inc. | 1993 | — |
| 0 (this device) | 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 | — |
| +1 | K132496 | Arthrosurface Toemotion | Arthrosurface, Inc. | 2014 | 1 |
| +2 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| +2 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| +3 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K920446 | Total Toe SystemSummary page 1…rained Product Code: LZJ Proposed Regulatory Class: unclassified (reason: Pre-Amendment) Predicate Device: - Biomet Total Toe System, K920446 - Kinetikos Medical Kinetik Great Toe System, K924724 Device Description: The Merete ToeMobile~m Anatomical Great Toe Resurf… | 1993 |
| * | K924724 | Kinetik Great Toe SystemSummary page 1…egulatory Class: unclassified (reason: Pre-Amendment) Predicate Device: - Biomet Total Toe System, K920446 - Kinetikos Medical Kinetik Great Toe System, K924724 Device Description: The Merete ToeMobile~m Anatomical Great Toe Resurfacing System is a two-piece prosthesis that replaces the m… | 1994 |
What descends from it? (9)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K102549 (Ascension Orthopedics, Inc., 2010) has gone furthest, with 8 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. 2008, 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 Merete ToeMobileTM Anatomical Great Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint.
The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change
- Hallux 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/K072251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072251: Merete Toemobile Anatomical Great Toe Resurfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072251
Report an extraction error
Are you the manufacturer?
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