510(k) · Cleared
ClearedOS2-C Compression 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 18, 2016 as substantially equivalent to K112794 (TriMed, Inc., 2012) and 3 other predicates after an 86-day review. Its family tree reaches back 6 generations to 1992. 7 later devices descend from it.
- Decided
- Feb 18, 2016
- Review
- 86 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K915818 (1992). 46 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 5 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 4 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 3 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 2 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- 1 generation backK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- This deviceK153395 OS2-C Compression StapleIn2bones Sas · 2016
- Descendant · cites it directly · 3 of its ownK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- Descendant · cites it directly · 2 of its ownK212594 OSSIOfiber® StapleOSSIO, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK220181 StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022
- Descendant · 2 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- K163440Stealth Staple SystemFirst Ray, LLC · 2017 · cites it directly3descendants
- K212594OSSIOfiber® StapleOSSIO, Ltd. · 2022 · cites it directly2descendants
- K233302OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023 · 2 generations on1descendant
- K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022 · 2 generations on1descendant
- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −5 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −4 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −3 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −2 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| −1 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| 0 (this device) | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| +1 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| +1 | K212594 | OSSIOfiber® Staple | OSSIO, Ltd. | 2022 | — |
| +2 | K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2023 | — |
| +2 | K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022 | — |
| +2 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K112794 | Eos Small Bone Fixation SystemSummary page 5…surgery center where sterile field may be created and maintained. Predicate Devices Biotech International / EOS Eleos Memory Staple (K112794) Integra / Newdeal UNI-CLIP (K011716) Memometal Easyclip (K070031)… | 2012 |
| * | K011716 | The Uni-Clip StapleSummary page 5…maintained. Predicate Devices Biotech International / EOS Eleos Memory Staple (K112794) Integra / Newdeal UNI-CLIP (K011716) Memometal Easyclip (K070031) Smith and Nephew Bioraptor 2.3 PK suture anch… | 2001 |
| * | K070031 | Memometal Memory StaplesSummary page 5…Biotech International / EOS Eleos Memory Staple (K112794) Integra / Newdeal UNI-CLIP (K011716) Memometal Easyclip (K070031) Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) - PEEK Indications for use: The OS2®… | 2007 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 5…Integra / Newdeal UNI-CLIP (K011716) Memometal Easyclip (K070031) Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) - PEEK Indications for use: The OS2®-C Compression Staples are indicated for fixation of arthr… | 2007 |
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 14 of the 46 ancestors have a recall of any class.
- Of its descendants, K163440 (First Ray, LLC, 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K112794.
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®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be adapted to the indication.
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/K153395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153395: OS2-C Compression Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153395
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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