510(k) Report

510(k) · Cleared

Cleared

Super Revo Suture Anchor

K003984510(k) TraditionalCleared Mar 19, 200183-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Linvatec Corp. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Mar 19, 2001 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 86 later devices descend from it.

Decided
Mar 19, 2001
Review
83 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

86 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2004: 1 descendant cleared2019: 7 descendants cleared2007: 2 descendants cleared2020: 5 descendants cleared2006: 1 descendant cleared2008: 3 descendants cleared2009: 1 descendant cleared2023: 12 descendants cleared2017: 7 descendants cleared2018: 5 descendants cleared2010: 1 descendant cleared2011: 5 descendants cleared2012: 2 descendants cleared2013: 4 descendants cleared2026: 4 descendants cleared2022: 3 descendants cleared2025: 10 descendants cleared2021: 3 descendants cleared2016: 1 descendant cleared2014: 4 descendants cleared2015: 1 descendant cleared2024: 3 descendants cleared200020052010201520202025
  1. This deviceK003984 Super Revo Suture AnchorLinvatec Corp. · 2001
  2. Descendant · cites it directly · 84 of its ownK041713 Super Revo Herculine Suture AnchorLinvatec Corp. · 2004
  3. Descendant · 2 generations on · 57 of its ownK073481 Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec · 2008
  4. Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
  5. Descendant · 4 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
  6. Descendant · 2 generations on · 19 of its ownK061294 KFX Knotless Fixation SystemKfx Medical · 2006

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12007: 22008: 32009: 12010: 12011: 52012: 22013: 42014: 42015: 12016: 12017: 72018: 52019: 72020: 52021: 32022: 32023: 122024: 32025: 102026: 4
2004high 12 (2023) · low 1 (2004)2026

Most influential descendants

Showing 5 of 86 · See all
  • K041713Super Revo Herculine Suture AnchorLinvatec Corp. · 2004 · cites it directly84descendants
  • K073481Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec · 2008 · 2 generations on57descendants
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 3 generations on56descendants
  • K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 4 generations on29descendants
  • K061294KFX Knotless Fixation SystemKfx Medical · 2006 · 2 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003984Super Revo Suture AnchorLinvatec Corp.2001—
+1K041713Super Revo Herculine Suture AnchorLinvatec Corp.2004—
+2K073481Threvo Anchor, Disposable Driver, HI-FI SuturesConmed Linvatec2008—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.20091
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec2011—
+2K061294KFX Knotless Fixation SystemKfx Medical2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200720
200830
200910
201010
201150
201220
201340
201440
201510
201610
201770
201850
201970
202050
202130
202230
2023120
202430
2025100
202640
FIG. 1 — Lineage of K003984, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (86)

See all 86

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041713Super Revo Herculine Suture AnchorLinvatec Corp.200484
K050227Threvo Suture Anchor with Disposable DriverLinvatec Corp.20050

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, K041713 (Linvatec Corp., 2004) has gone furthest, with 84 descendants of its own.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

More from Linvatec Corp.

93 FDA decisions under this applicant name. See the company

  • K092998Conmed Linvatec Intercept ImplantLinvatec Corp. · 2009
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 20091 recall
  • K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
  • K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp. · 2009
  • K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave…Linvatec Corp. · 2009

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K003984 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003984: Super 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/K003984

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026