510(k) · Cleared
ClearedOsteomed Great Toe System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Cleared on Nov 9, 1993 after a 546-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Nov 9, 1993
- Review
- 546 days
- Class
- Class U
- Product code
- LZJ
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK922211 Osteomed Great Toe SystemOsteomed Corp. · 1993
- Descendant · cites it directly · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- Descendant · 2 generations on · 13 of its ownK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- Descendant · 3 generations on · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- Descendant · 2 generations on · 10 of its ownK113752 Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012
- Descendant · 3 generations on · 9 of its ownK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · cites it directly15descendants
- K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008 · 2 generations on13descendants
- K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · 3 generations on11descendants
- K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012 · 2 generations on10descendants
- K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922211 | Osteomed Great Toe System | Osteomed Corp. | 1993 | — |
| +1 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| +2 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| +3 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| +2 | K113752 | Metatarsal Decompression Implant Surgical Instrument Set | Solana Surgical, LLC | 2012 | — |
| +3 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073065 | Osteomed Metatarsal Resurfacing Implant System | 2008 | 15 |
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, K073065 (Osteomed LP, 2008) has gone furthest, with 15 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/K922211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922211: Osteomed Great Toe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922211
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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