510(k) · Cleared
ClearedOSSIOfiber® Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OSSIO, Ltd. · MNU Staple, Absorbable
Cleared on Jan 21, 2022 as substantially equivalent to K153395 (In2bones Sas, 2016) after a 158-day review. Its family tree reaches back 7 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 21, 2022
- Review
- 158 days
- Class
- Class II
- Product code
- MNU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K915818 (1992). 47 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 6 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 5 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 4 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 3 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- 2 generations backK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- 1 generation backK153395 OS2-C Compression StapleIn2bones Sas · 2016
- This deviceK212594 OSSIOfiber® StapleOSSIO, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −6 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −5 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −4 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −3 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| −2 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| −1 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| 0 (this device) | K212594 | OSSIOfiber® Staple | OSSIO, Ltd. | 2022 | — |
| +1 | K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 MNU? 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 MNU device
- #1 K233302 OSSIOfiber® Compression Staplescore 11.5 · 8 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K153395 | OS2-C Compression StapleSummary page 4…allic bone fixation appliances and accessories Regulatory Class: Class II, 21 C.F.R. § 888.3030 Product Code: MNU Predicate Devices OS2®-C Compression Staple (K153395) – Primary Predicate Reference Devices OSSIO® Pin Product Family (K181180) OSSIOfiber® Hammertoe Fixation System… | 2016 |
| † | K181180 | OSSIO™ Pin Product Family | 2019 |
| † | K190652 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | 2020 |
| † | K201803 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | 2020 |
| † | K193660 | OSSIOfiber™ Compression Screws | 2020 |
What descends from it? (2)
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 30 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 14 of the 47 ancestors have a recall of any class.
- Of its descendants, K233302 (OSSIO, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K153395.
How does its category compare?
All MNU devicesMNU Staple, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MNU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNU
Too few MNU 510(k)s in any year since 2007 to give a median.
Recalls per year · MNU
No recall names MNU since 2007.
Adverse event reports per year · MNU
4in 2024
MAUDE reports naming product code MNU, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization.
The number and size of the OSSIOfiber® Staples must be adapted to the indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212594: OSSIOfiber® Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212594
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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