510(k) · Cleared

Cleared

Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture (210809), and Panacryl Suture (210810)

K063478510(k) SpecialCleared Dec 15, 200628-day reviewClass II21 CFR 888.3040

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

Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone

Cleared on Dec 15, 2006 as substantially equivalent to K060914 (Johnson & Johnson Company, 2006) after a 28-day review. Its family tree reaches back 3 generations to 2001. 32 later devices descend from it.

Decided: Dec 15, 2006
Review: 28 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K012125 (2001). 7 ancestors in all, the oldest K971723 (1997). 32 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
2 generations backK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
1 generation backK060914 Trident AnchorJohnson & Johnson Company · 2006
This deviceK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006
Descendant · cites it directly · 27 of its ownK171020 Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017
Descendant · 2 generations on · 16 of its ownK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
Descendant · 3 generations on · 6 of its ownK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
Descendant · 4 generations on · 5 of its ownK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
Descendant · 3 generations on · 5 of its ownK231113 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2023

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2009high 8 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 32 · See all

K171020Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017 · cites it directly27descendants
K203268Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 2 generations on16descendants
K230568FiberTak Suture AnchorArthrex, Inc. · 2023 · 3 generations on6descendants
K231330FiberTak® Suture AnchorArthrex, Inc. · 2023 · 4 generations on5descendants
K231113Arthrex FiberTak Suture AnchorArthrex, Inc. · 2023 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K012125	Opus Magnum Anchor & Inserter	Opus Medical, Inc.	2001	—
−2	K042914	Opus Magnum Knotless Anchor with Inserter Handle	Opus Medical, Inc.	2004	—
−1	K060914	Trident Anchor	Johnson & Johnson Company	2006	—
0 (this device)	K063478	Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond…	Depuy Mitek, A Johnson & Johnson Company	2006	—
+1	K171020	Arthrex Knotless SutureTak Anchor	Arthrex, Inc.	2017	—
+2	K203268	Arthrex FiberTak Suture Anchor	Arthrex, Inc.	2020	—
+3	K230568	FiberTak Suture Anchor	Arthrex, Inc.	2023	—
+4	K231330	FiberTak® Suture Anchor	Arthrex, Inc.	2023	—
+3	K231113	Arthrex FiberTak Suture Anchor	Arthrex, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
2000	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2012	1	0
2017	1	0
2018	2	0
2019	3	0
2020	2	0
2022	3	0
2023	8	0
2024	1	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K063478, 2001–2026Source: 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
*	K060914	Trident Anchor Summary page 1 …Proprietary Name: Versalok Anchor Substantial Equivalence Versalok Anchor is substantially equivalent to: Trident Anchor (K0609 14) Device Classification The Versalok Anchor device carries an FDA product code MBI and HWC, and…	Johnson & Johnson Company	2006	—

Also cleared against K060914: 1 other device →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K171020	Arthrex Knotless SutureTak Anchor	Arthrex, Inc.	2017	27
K090530	Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01	Ross Creek Medical, Inc.	2009	2
K180594	Knotless SutureTak Anchors	Arthrex, Inc.	2018	1
K100532	Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819	Depuy Mitek, A Johnson & Johnson Company	2010	0

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 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K171020 (Arthrex, Inc., 2017) has gone furthest, with 27 descendants of its own.
1 other device also cites its predicate K060914.

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?

VERSALOK Anchor is indicated for use in the following:

Shoulder: Rotator Cuff Repair, Biceps Tenodesis

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure

Elbow: Biceps Tendon Reattachment

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063478 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063478: Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture (210809), and Panacryl Suture (210810).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063478

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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