510(k) · Cleared
ClearedMemometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memometal Technologies · JDR Staple, Fixation, Bone
Cleared on Mar 19, 2007 after a 75-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Mar 19, 2007
- Review
- 75 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK070033 Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10Memometal Technologies · 2007
- Descendant · cites it directly · 9 of its ownK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK153395 OS2-C Compression StapleIn2bones Sas · 2016
- Descendant · cites it directly · 5 of its ownK143323 OS2-V Varisation StapleIn2bones Sas · 2015
- Descendant · 2 generations on · 4 of its ownK153770 OS2(R)-VP Varisation StapleIn2bones Sas · 2016
- Descendant · 3 generations on · 3 of its ownK163440 Stealth Staple SystemFirst Ray, LLC · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K112794Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · cites it directly9descendants
- K153395OS2-C Compression StapleIn2bones Sas · 2016 · 2 generations on7descendants
- K143323OS2-V Varisation StapleIn2bones Sas · 2015 · cites it directly5descendants
- K153770OS2(R)-VP Varisation StapleIn2bones Sas · 2016 · 2 generations on4descendants
- K163440Stealth Staple SystemFirst Ray, LLC · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10 | Memometal Technologies | 2007 | — |
| +1 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| +2 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| +1 | K143323 | OS2-V Varisation Staple | In2bones Sas | 2015 | — |
| +2 | K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | 2016 | — |
| +3 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 JDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | (DEPUY Inc) varisation staple Named without a submission number |
What descends from it? (16)
See all 163 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, K112794 (TriMed, Inc., 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The MEMOMETAL varisation staples (AV XX-YY) are indicated for Akin type osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070033: Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070033
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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