510(k) · Cleared
ClearedThrevo Anchor, Disposable Driver, HI-FI Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 7, 2008 as substantially equivalent to K041713 (Linvatec Corp., 2004) after a 27-day review. Its family tree reaches back 2 generations to 2001. 57 later devices descend from it.
- Decided
- Jan 7, 2008
- Review
- 27 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003984 (2001). 57 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003984 Super Revo Suture AnchorLinvatec Corp. · 2001
- 1 generation backK041713 Super Revo Herculine Suture AnchorLinvatec Corp. · 2004
- This deviceK073481 Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec · 2008
- Descendant · cites it directly · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- Descendant · 2 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · 3 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 · 4 generations on · 12 of its ownK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK163258 CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · cites it directly56descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 2 generations on29descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 3 generations on17descendants
- K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation · 2014 · 4 generations on12descendants
- K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003984 | Super Revo Suture Anchor | Linvatec Corp. | 2001 | — |
| −1 | K041713 | Super Revo Herculine Suture Anchor | Linvatec Corp. | 2004 | — |
| 0 (this device) | K073481 | Threvo Anchor, Disposable Driver, HI-FI Sutures | Conmed Linvatec | 2008 | — |
| +1 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| +2 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +3 | 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 | — |
| +4 | K133224 | Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2… | Conmed Corporation | 2014 | — |
| +2 | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 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 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 |
|---|---|---|---|
| * | K041713 | Super Revo Herculine Suture AnchorSummary page 1…(k) Name Classification Classification Name 510(k) # Owner Panel Super Revo Orthopedic Screw, Fastener, K041713 Linvatec Herculine Fixation, Corporation Suture Ancho… | 2004 |
What descends from it? (57)
See all 571 later device cites 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 |
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 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091549 (Linvatec Corp., 2009) has gone furthest, with 56 descendants of its own.
- 4 other devices also cite its predicate K041713.
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. 2008, this device’s year, is highlighted.
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 ThRevo® Anchor, Disposable Driver, Hi-FiTM Sutures 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/K073481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073481: Threvo Anchor, Disposable Driver, HI-FI Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073481
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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