510(k) · Cleared
ClearedOSSIOfiber® Compression 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 Nov 16, 2023 as substantially equivalent to K153770 (In2bones Sas, 2016) and 1 other predicate after a 48-day review. Its family tree reaches back 8 generations to 1992. 1 later device descends from it.
- Decided
- Nov 16, 2023
- Review
- 48 days
- Class
- Class II
- Product code
- MNU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K915818 (1992). 54 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 7 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 6 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 5 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 4 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- 3 generations backK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- 2 generations backK153395 OS2-C Compression StapleIn2bones Sas · 2016
- 1 generation backK212594 OSSIOfiber® StapleOSSIO, Ltd. · 2022
- This deviceK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −7 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −6 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −5 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −4 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| −3 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| −2 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| −1 | K212594 | OSSIOfiber® Staple | OSSIO, Ltd. | 2022 | — |
| 0 (this device) | 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 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K212594 OSSIOfiber® Staplescore 10.5 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K153770 | OS2(R)-VP Varisation StapleSummary page 5…lic bone fixation appliances and accessories Regulatory Class: Class II, 21 C.F.R. § 888.3030 Product Code: MNU Predicate Devices OS2®-VP Varisation Staple (K153770) - Primary Predicate OSSIOfiber® Compression Staple (K212594) Reference Device OSSIOfiber® Cannulated T… | 2016 |
| * | K212594 | OSSIOfiber® StapleSummary page 5…1 C.F.R. § 888.3030 Product Code: MNU Predicate Devices OS2®-VP Varisation Staple (K153770) - Primary Predicate OSSIOfiber® Compression Staple (K212594) Reference Device OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465) OSSIOfiber® Compression Scre… | 2022 |
| † | K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail… | 2021 |
| † | K193660 | OSSIOfiber™ Compression Screws | 2020 |
| † | K213596 | OSSIOfiber Compression Screw, 3.5mm | 2021 |
| † | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241932 | OSSIOfiber® Compression Staple | 2024 | 0 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 14 of the 54 ancestors have a recall of any class.
- Of its descendants, K241932 (OSSIO, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153770.
How does its category compare?
All MNU devicesMNU Staple, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
OSSIOfiber® Compression 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® Compression Staples must be adapted to the indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233302: OSSIOfiber® Compression Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233302
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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