510(k) · Cleared
ClearedArthrex Bio-Transfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MNU Staple, Absorbable
Cleared on Jun 19, 2001 after a 63-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jun 19, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- MNU
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK011172 Arthrex Bio-TransfixArthrex, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK021351 Biosteon Cross PinBiocomposites, Ltd. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK043106 Pinn-Acl CrosspinLinvatec Corp. · 2005
- Descendant · cites it directly · 0 of its ownK033792 Bilok ST ScrewBiocomposites, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK014305 Resorbable Lactosorb-L Acl CrosspinArthrotek, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K021351Biosteon Cross PinBiocomposites, Ltd. · 2002 · cites it directly1descendant
- K043106Pinn-Acl CrosspinLinvatec Corp. · 2005 · cites it directly0descendants
- K033792Bilok ST ScrewBiocomposites, Ltd. · 2004 · cites it directly0descendants
- K014305Resorbable Lactosorb-L Acl CrosspinArthrotek, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011172 | Arthrex Bio-Transfix | Arthrex, Inc. | 2001 | — |
| +1 | K021351 | Biosteon Cross Pin | Biocomposites, Ltd. | 2002 | 1 |
| +1 | K043106 | Pinn-Acl Crosspin | Linvatec Corp. | 2005 | — |
| +1 | K033792 | Bilok ST Screw | Biocomposites, Ltd. | 2004 | — |
| +1 | K014305 | Resorbable Lactosorb-L Acl Crosspin | Arthrotek, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
4 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, K021351 (Biocomposites, Ltd., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MNU devicesMNU Staple, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopedic procedures.
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/K011172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011172: Arthrex Bio-Transfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011172
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026