510(k) · Cleared
ClearedOS2(R)-VP 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 Mar 21, 2016 as substantially equivalent to K143323 (In2bones Sas, 2015) and 2 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it.
- Decided
- Mar 21, 2016
- Review
- 82 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K902307 (1990). 10 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 2 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 1 generation backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- This deviceK153770 OS2(R)-VP Varisation StapleIn2bones Sas · 2016
- Descendant · cites it directly · 1 of its ownK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK170688 PIT’Stop® implantIn2bones Sas · 2017
- Descendant · 2 generations on · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
Most influential descendants
Showing 4 of 4 · See all- K233302OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023 · cites it directly1descendant
- K170688PIT’Stop® implantIn2bones Sas · 2017 · cites it directly1descendant
- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · 2 generations on0descendants
- K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −2 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −1 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| 0 (this device) | K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | 2016 | — |
| +1 | K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2023 | — |
| +1 | K170688 | PIT’Stop® implant | In2bones Sas | 2017 | — |
| +2 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
| +2 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K143323 | OS2-V Varisation StapleSummary page 5…field may be created and maintained. Predicate Devices Primary predicate device: In2Bones OS2®-V Varisation Staple (K143323) Additional predicate device: Memometal Easyclip (K070031) N… | 2015 |
| * | K070031 | Memometal Memory StaplesSummary page 5…device: In2Bones OS2®-V Varisation Staple (K143323) Additional predicate device: Memometal Easyclip (K070031) Newdeal K Wire (K022599) Reference predicate devices: In2Bo… | 2007 |
| * | K022599 | Newdeal K WireSummary page 5…arisation Staple (K143323) Additional predicate device: Memometal Easyclip (K070031) Newdeal K Wire (K022599) Reference predicate devices: In2Bones DUAFIT® Interphalangeal Implant (K132912) In… | 2002 |
| † | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | 2014 |
What descends from it? (4)
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K233302 (OSSIO, Ltd., 2023) has gone furthest, with 1 descendant 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. 2016, 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®-VP Varisation Staples are indicated for Akin type osteotomies.
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/K153770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153770: OS2(R)-VP 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/K153770
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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