510(k) · Cleared
ClearedOS2-V Varisation Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · JDR Staple, Fixation, Bone
Cleared on Feb 26, 2015 as substantially equivalent to K991566 (New Deal, S.A., 1999) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Feb 26, 2015
- Review
- 99 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991566 (1999). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK991566 SolustapleNew Deal, S.A. · 1999
- This deviceK143323 OS2-V Varisation StapleIn2bones Sas · 2015
- Descendant · cites it directly · 4 of its ownK153770 OS2(R)-VP Varisation StapleIn2bones Sas · 2016
- Descendant · 2 generations on · 1 of its ownK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK170688 PIT’Stop® implantIn2bones Sas · 2017
- Descendant · 3 generations on · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
Most influential descendants
Showing 5 of 5 · See all- K153770OS2(R)-VP Varisation StapleIn2bones Sas · 2016 · cites it directly4descendants
- K233302OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023 · 2 generations on1descendant
- K170688PIT’Stop® implantIn2bones Sas · 2017 · 2 generations on1descendant
- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · 3 generations on0descendants
- K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991566 | Solustaple | New Deal, S.A. | 1999 | — |
| 0 (this device) | K143323 | OS2-V Varisation Staple | In2bones Sas | 2015 | — |
| +1 | K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | 2016 | — |
| +2 | K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2023 | — |
| +2 | K170688 | PIT’Stop® implant | In2bones Sas | 2017 | — |
| +3 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
| +3 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K991566 | SolustapleSummary page 5…l, or outpatient surgery center where sterile field may be created and maintained. Predicate Devices Integra / Newdeal SOLUSTAPLE (K991566) Memometal Varisation staple (K070033) Indications for use: The OS2®-V Varisation Staples are… | 1999 |
| * | K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10Summary page 5…be created and maintained. Predicate Devices Integra / Newdeal SOLUSTAPLE (K991566) Memometal Varisation staple (K070033) Indications for use: The OS2®-V Varisation Staples are indicated for Akin type osteotomies… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153770 | OS2(R)-VP Varisation Staple | 2016 | 4 |
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?
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 OS2®-V Varisation Staples are indicated for Akin type osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143323: OS2-V Varisation Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143323
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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