510(k) · Cleared

Recalled · 2005

Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture

K042778510(k) SpecialCleared Nov 4, 200429-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 Nov 4, 2004 as substantially equivalent to K033804 (Linvatec Corp., 2003) after a 29-day review. Its family tree reaches back 1 generation to 2003. 6 later devices descend from it. It has been recalled once.

Decided: Nov 4, 2004
Review: 29 days
Class: Class II
Product code: HWC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K033804 (2003). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK033804 Bioanchor with Disposable DriverLinvatec Corp. · 2003 · Recalled
This deviceK042778 Bioanchor with Disposable Driver, Preloaded with One #2 Herculine…Linvatec Corp. · 2004
Descendant · cites it directly · 4 of its ownK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
Descendant · 2 generations on · 1 of its ownK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
Descendant · 2 generations on · 0 of its ownK193558 HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc. · 2020
Descendant · 3 generations on · 0 of its ownK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK142948 BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009high 2 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all

K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013 · cites it directly4descendants
K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc. · 2015 · 2 generations on1descendant
K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc. · 2020 · 2 generations on0descendants
K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017 · 3 generations on0descendants
K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033804	Bioanchor with Disposable Driver	Linvatec Corp.	2003	1
0 (this device)	K042778	Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture	Linvatec Corp.	2004	—
+1	K123393	Healicoil Suture Anchor with Regenesorb	Smith & Nephew, Inc.	2013	—
+2	K151105	Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and…	Smith & Nephew, Inc.	2015	40
+2	K193558	HEALICOIL Knotless Suture Anchors	Smith & Nephew, Inc.	2020	—
+3	K163672	Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor	Nanova Biomaterials, Inc.	2017	—
+2	K142948	BIOSURE REGENESORB interference Screw	Smith & Nephew, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2013	1	0
2015	2	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K042778, 2003–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K033804	Bioanchor with Disposable Driver Summary page 2 …, Preloaded with One Suture 510(k)# o/>77- October 1, 2004 D. Predicate/Legally Marketed Devices BioAnchore with Disposable Driver 510(k) # K033804 Linvatec Corporation E. Device Description with One…	Linvatec Corp.	2003	1

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K123393	Healicoil Suture Anchor with Regenesorb	Smith & Nephew, Inc.	2013	4
K092898	Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI Sutures	Conmed Linvatec	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 22, 2005	Not classified	Z-1548-05	Other	Linvatec has determined there is a possibility 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 potential for…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K123393 (Smith & Nephew, Inc., 2013) has gone furthest, with 4 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

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

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

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

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 BioAnchor® with Disposable Driver, Preloaded with One #2 HerculineTM Suture is intended for soft tissue repair of the shoulder; specifically, Bankhart and SLAP repair, capsular shifts and capsulolabral reconstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042778: Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042778

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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