510(k) · Cleared
ClearedThe Ascension Movement Great Toe System Total Arthroplasty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Cleared on Dec 21, 2010 as substantially equivalent to K924724 (Kinetikos Medical, Inc., 1994) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 1993. 8 later devices descend from it.
- Decided
- Dec 21, 2010
- Review
- 105 days
- Class
- Class U
- Product code
- LZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920446 (1993). 3 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK920446 Total Toe SystemBiomet, Inc. · 1993
- 1 generation backK072251 Merete Toemobile Anatomical Great Toe Resurfacing SystemMerete Medical GmbH · 2008
- This deviceK102549 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
- Descendant · 3 generations on · 1 of its ownK222964 BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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
- K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920446 | Total Toe System | Biomet, Inc. | 1993 | — |
| −1 | K072251 | Merete Toemobile Anatomical Great Toe Resurfacing System | Merete Medical GmbH | 2008 | — |
| 0 (this device) | 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 | — |
| +3 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K924724 | Kinetik Great Toe SystemSummary page 1…J PANEL: Orthopedic PREDICATE DEVICES: KGTI Kinetik Great Toe Implant System, Integra Lifesciences, K924724 Merete ToeMobile Tm Anatomical Great Toe Resurfacing System, Mere… | 1994 |
| * | K072251 | Merete Toemobile Anatomical Great Toe Resurfacing SystemSummary page 1…Merete ToeMobile Tm Anatomical Great Toe Resurfacing System, Merete Medical, K072251 DEVICE DESCRIPTION: The Ascensione MOVEMENT Great Toe System, Total Arthroplasty devi… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132496 | Arthrosurface Toemotion | 2014 | 7 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132496 (Arthrosurface, Inc., 2014) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K924724.
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. 2010, 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 Ascension® MOVEMENT TM Great Toe System, Total Arthroplasty 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
* 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/K102549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102549: The Ascension Movement Great Toe System Total Arthroplasty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102549
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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