510(k) · Cleared
ClearedSolustaple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · JDR Staple, Fixation, Bone
Cleared on Aug 3, 1999 after a 90-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Aug 3, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK991566 SolustapleNew Deal, S.A. · 1999
- 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 · 1 of its ownK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK170688 PIT’Stop® implantIn2bones Sas · 2017
- Descendant · 4 generations on · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K143323OS2-V Varisation StapleIn2bones Sas · 2015 · cites it directly5descendants
- K153770OS2(R)-VP Varisation StapleIn2bones Sas · 2016 · 2 generations on4descendants
- K233302OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023 · 3 generations on1descendant
- K170688PIT’Stop® implantIn2bones Sas · 2017 · 3 generations on1descendant
- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991566 | Solustaple | New Deal, S.A. | 1999 | — |
| +1 | K143323 | OS2-V Varisation Staple | In2bones Sas | 2015 | — |
| +2 | K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | 2016 | — |
| +3 | K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2023 | — |
| +3 | K170688 | PIT’Stop® implant | In2bones Sas | 2017 | — |
| +4 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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? (7)
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, K143323 (In2bones Sas, 2015) has gone furthest, with 5 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.
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 SOLUSTAPLE ® is indicated for:
® Akin type osteotomy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991566: Solustaple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991566
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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