510(k) · Cleared
ClearedKinetik Great Toe System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetikos Medical, Inc. · LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Cleared on Jan 5, 1994 after a 471-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jan 5, 1994
- Review
- 471 days
- Class
- Class U
- Product code
- LZJ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK924724 Kinetik Great Toe SystemKinetikos Medical, Inc. · 1994
- Descendant · cites it directly · 9 of its ownK072251 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 · 2 generations on · 7 of its ownK132496 Arthrosurface ToemotionArthrosurface, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 6 of its ownK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K072251Merete Toemobile Anatomical Great Toe Resurfacing SystemMerete Medical GmbH · 2008 · cites it directly9descendants
- K102549The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 2010 · cites it directly8descendants
- K132496Arthrosurface ToemotionArthrosurface, Inc. · 2014 · 2 generations on7descendants
- K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016 · 3 generations on6descendants
- K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924724 | Kinetik Great Toe System | Kinetikos Medical, Inc. | 1994 | — |
| +1 | 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 | — |
| +2 | K132496 | Arthrosurface Toemotion | Arthrosurface, Inc. | 2014 | 1 |
| +3 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| +3 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
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?
- Of its descendants, K072251 (Merete Medical GmbH, 2008) has gone furthest, with 9 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.
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 | — |
https://510kreport.com/device/K924724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924724: Kinetik Great Toe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924724
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026