510(k) Report

510(k) · Cleared

Recalled · 2005

Bioanchor with Disposable Driver

K033804510(k) SpecialCleared Dec 31, 200323-day reviewClass II21 CFR 888.3040Recalls 1

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

Linvatec Corp. · HWC Screw, Fixation, Bone

Cleared on Dec 31, 2003 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.

Decided
Dec 31, 2003
Review
23 days
Class
Class II
Product code
HWC
Recalls
1
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2013: 1 descendant cleared2009: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK033804 Bioanchor with Disposable DriverLinvatec Corp. · 2003
  2. Descendant · cites it directly · 6 of its ownK042778 Bioanchor with Disposable Driver, Preloaded with One #2 Herculine…Linvatec Corp. · 2004 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
  4. Descendant · 3 generations on · 1 of its ownK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK193558 HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc. · 2020
  6. Descendant · 4 generations on · 0 of its ownK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12009: 12013: 12015: 22017: 12020: 1
2004high 2 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K042778Bioanchor with Disposable Driver, Preloaded with One #2 Herculine SutureLinvatec Corp. · 2004 · cites it directly6descendants
  • K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013 · 2 generations on4descendants
  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc. · 2015 · 3 generations on1descendant
  • K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc. · 2020 · 3 generations on0descendants
  • K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033804Bioanchor with Disposable DriverLinvatec Corp.2003—
+1K042778Bioanchor with Disposable Driver, Preloaded with One #2 Herculine SutureLinvatec Corp.20041
+2K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.2013—
+3K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and…Smith & Nephew, Inc.201540
+3K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.2020—
+4K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200910
201310
201520
201710
202010
FIG. 1 — Lineage of K033804, 2003–2020Source: 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 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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042778Bioanchor with Disposable Driver, Preloaded with One #2 Herculine SutureLinvatec Corp.20046

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 22, 2005Not classifiedZ-1547-05OtherLinvatec has determined that there is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K042778 (Linvatec Corp., 2004) has gone furthest, with 6 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

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 HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K033804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033804: Bioanchor with Disposable Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033804

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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