510(k) · Cleared
ClearedBio-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 Feb 23, 2006 as substantially equivalent to K042966 (Linvatec Biomaterials, Ltd., 2004) and 5 other predicates after a 64-day review. Its family tree reaches back 7 generations to 1991. 75 later devices descend from it.
- Decided
- Feb 23, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K911837 (1991). 54 ancestors in all, the oldest K792022 (1979). 75 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 6 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 5 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 4 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 3 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 2 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 1 generation backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- This deviceK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- Descendant · cites it directly · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- Descendant · cites it directly · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · cites it directly · 25 of its ownK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- Descendant · 2 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- Descendant · 2 generations on · 13 of its ownK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · cites it directly56descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · cites it directly29descendants
- K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008 · cites it directly25descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 2 generations on17descendants
- K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −6 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −5 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −4 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −3 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −2 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −1 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| 0 (this device) | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| +1 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| +1 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +1 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| +2 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
| +2 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
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 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Summary page 2…e 2 === Summary of Safety and Effectiveness Bio-Mini Revo Suture Anchor 510(k) # -_ December 16, 2005 Page 2 of 3 1). Predicate/Legally Marketed Devices K042966 - Duet and Impact Suture Anchor (Linvatec Biomaterials) K030388 - Impact Suture Anchor (Linvatec Biomaterials) K0… | 2004 |
| * | K030388 | Impact Suture Anchor. Model 433510Summary page 2…510(k) # -_ December 16, 2005 Page 2 of 3 1). Predicate/Legally Marketed Devices K042966 - Duet and Impact Suture Anchor (Linvatec Biomaterials) K030388 - Impact Suture Anchor (Linvatec Biomaterials) K020056 - Duet Suture Anchor (Linvatec Biomaterials) K050497 - Bio… | 2003 |
| * | K020056 | Duet Suture AnchorSummary page 2…/Legally Marketed Devices K042966 - Duet and Impact Suture Anchor (Linvatec Biomaterials) K030388 - Impact Suture Anchor (Linvatec Biomaterials) K020056 - Duet Suture Anchor (Linvatec Biomaterials) K050497 - BioScrew XtraLok (ConMed Linvatec) K020377 - BioStinger -V… | 2002 |
| * | K050497 | Bioscrew Xtralok, 8X35MM & 8X40MM VioletSummary page 2…Suture Anchor (Linvatec Biomaterials) K030388 - Impact Suture Anchor (Linvatec Biomaterials) K020056 - Duet Suture Anchor (Linvatec Biomaterials) K050497 - BioScrew XtraLok (ConMed Linvatec) K020377 - BioStinger -V Bioabsorbable Meniscal Repair Device (ConMed Linvatec)… | 2005 |
| * | K020377 | Pre-Loaded Biostinger HornetSummary page 2…- Impact Suture Anchor (Linvatec Biomaterials) K020056 - Duet Suture Anchor (Linvatec Biomaterials) K050497 - BioScrew XtraLok (ConMed Linvatec) K020377 - BioStinger -V Bioabsorbable Meniscal Repair Device (ConMed Linvatec) K991715 - BioStinger -V Bioabsorbable Meniscal Rep… | 2002 |
| * | K991715 | Biostinger-V Bioabsorbable Meniscal Repair DeviceSummary page 2…invatec Biomaterials) K050497 - BioScrew XtraLok (ConMed Linvatec) K020377 - BioStinger -V Bioabsorbable Meniscal Repair Device (ConMed Linvatec) K991715 - BioStinger -V Bioabsorbable Meniscal Repair Device (ConMed Linvatec) E. Device Description The Linvatec Bio-Mini-… | 1999 |
What descends from it? (75)
See all 757 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091549 | Conmed Linvatec Soft Tissue to Bone System | 2009 | 56 |
| K111779 | Y-Knot All-Suture Anchor Model HF13 | 2011 | 29 |
| K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | 2008 | 25 |
| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR | 2009 | 10 |
| K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 | 2010 | 5 |
| K092898 | Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI Sutures | 2009 | 0 |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI Sutures | 2009 | 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 15 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 54 ancestors have a recall of any class.
- Of its descendants, K091549 (Linvatec Corp., 2009) has gone furthest, with 56 descendants of its own.
- 1 other device also cites its predicate K042966.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053561: 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/K053561
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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