510(k) · Cleared
ClearedConmed Linvatec Bio Mini-Revo Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · HWC Screw, Fixation, Bone
Cleared on Jul 14, 2008 as substantially equivalent to K053561 (Conmed Linvatec, 2006) and 1 other predicate after a 333-day review. Its family tree reaches back 8 generations to 1991. 25 later devices descend from it.
- Decided
- Jul 14, 2008
- Review
- 333 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911837 (1991). 59 ancestors in all, the oldest K792022 (1979). 25 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 7 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 6 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 5 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 4 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 3 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 2 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 1 generation backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- This deviceK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- Descendant · cites it directly · 13 of its ownK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- Descendant · cites it directly · 10 of its ownK090835 Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
- Descendant · 2 generations on · 9 of its ownK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · Recalled
- Descendant · 2 generations on · 7 of its ownK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- Descendant · 3 generations on · 5 of its ownK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009 · cites it directly13descendants
- K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009 · cites it directly10descendants
- K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · 2 generations on9descendants
- K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009 · 2 generations on7descendants
- K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −7 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −6 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −5 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −4 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −3 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −2 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −1 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| 0 (this device) | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| +1 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
| +1 | K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR | Linvatec Corp. | 2009 | — |
| +2 | K112965 | Nano Suture Anchor | Linvatec Corporation D/B/A Conmed Linvatec | 2011 | 6 |
| +2 | K091094 | Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264 | Parcus Medical, LLC | 2009 | — |
| +3 | K102326 | Parcus 3.5MM Peek CF Push-in Suture Anchor | Parcus Medical, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K053561 | Bio-Mini Revo Suture AnchorSummary page 1…for the Bio Mini-Revo are: Device name: Bio Mini-Revo Company name: ConMed Linvatec 510(k)#: K053561 Page 1 of 2 510(k) Summary… | 2006 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 2…ed Linvatec Bio Mini-Revo Suture Anchor June 30, 2008 Device name: Bio-FASTak Suture Anchor Company name: Arthrex 510(k) #: K061863 E. Device Description The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in suture an… | 2006 |
What descends from it? (25)
See all 252 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 17 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 59 ancestors have a recall of any class.
- Of its descendants, K090075 (Parcus Medical, LLC, 2009) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K053561.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Bio Mini-Revo Suture Anchor is intended to reattach soft tissue to bone in
arthroscopic or open hip procedures; such as acetabular labral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072291: Conmed Linvatec Bio Mini-Revo Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072291
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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