510(k) · Cleared
ClearedSuper Revo Herculine Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 22, 2004 as substantially equivalent to K003984 (Linvatec Corp., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 84 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003984 (2001). 84 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK003984 Super Revo Suture AnchorLinvatec Corp. · 2001
- This deviceK041713 Super Revo Herculine Suture AnchorLinvatec Corp. · 2004
- Descendant · cites it directly · 57 of its ownK073481 Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec · 2008
- Descendant · 2 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- Descendant · 3 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · cites it directly · 19 of its ownK061294 KFX Knotless Fixation SystemKfx Medical · 2006
- Descendant · 2 generations on · 18 of its ownK072063 KFX Tissue Fixation System and AccessoriesKfx Medical · 2007
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K073481Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec · 2008 · cites it directly57descendants
- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 2 generations on56descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 3 generations on29descendants
- K061294KFX Knotless Fixation SystemKfx Medical · 2006 · cites it directly19descendants
- K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003984 | Super Revo Suture Anchor | Linvatec Corp. | 2001 | — |
| 0 (this device) | K041713 | Super Revo Herculine Suture Anchor | Linvatec Corp. | 2004 | — |
| +1 | K073481 | Threvo Anchor, Disposable Driver, HI-FI Sutures | Conmed Linvatec | 2008 | — |
| +2 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| +3 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +1 | K061294 | KFX Knotless Fixation System | Kfx Medical | 2006 | — |
| +2 | K072063 | KFX Tissue Fixation System and Accessories | Kfx Medical | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 12 | 0 |
| 2024 | 3 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K003984 | Super Revo Suture AnchorSummary page 2…SuperRevo® HerculineTM Suture Anchor 510(k) #2P004CtL June 14, 2004 D. Predicate/Legally Marketed Devices Super Revo® Suture Anchor 510(k) # K003984 Linvatec Corporation E. Device Description The Super Revo® HerculineTM Suture Anchor is a titanium suture… | 2001 |
| † | K033654 | Force Fiber | 2004 |
| † | K040472 | Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture | 2004 |
What descends from it? (84)
See all 845 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?
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Super Revo® HerculineTM Suture Anchor is intended to be
used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open
technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041713 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041713: Super Revo Herculine Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041713
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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