510(k) · Cleared
ClearedVersalok Peek Anchor with Orthocord Suture, Models 210818, 210819
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone
Cleared on Mar 17, 2010 as substantially equivalent to K060914 (Johnson & Johnson Company, 2006) and 2 other predicates after a 20-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 17, 2010
- Review
- 20 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K012125 (2001). 10 ancestors in all, the oldest K971723 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
- 3 generations backK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
- 2 generations backK060914 Trident AnchorJohnson & Johnson Company · 2006
- 1 generation backK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006
- This deviceK100532 Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819Depuy Mitek, A Johnson & Johnson Company · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012125 | Opus Magnum Anchor & Inserter | Opus Medical, Inc. | 2001 | — |
| −3 | K042914 | Opus Magnum Knotless Anchor with Inserter Handle | Opus Medical, Inc. | 2004 | — |
| −2 | K060914 | Trident Anchor | Johnson & Johnson Company | 2006 | — |
| −1 | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond… | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| 0 (this device) | K100532 | Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819 | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060914 | Trident AnchorSummary page 1…: Versalok Peek Anchor Substantial Equivalence Versalok Peek Anchor is substantially equivalent to: Trident Anchor (K0609 14) Versalok Ti Anchor (K(063478) Anthrex Pushlock Anchor (K(063… | 2006 |
| * | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Summary page 2…ug and Cosmetic Act. Predicate Comparison The proposed Versalok Peek Anchor is compared to the predicate Trident Anchor (K063478), Versalok Anchor (K0609 14) and Arthrex Pushlock (K(063479) below. 5 10(k) Premarket Notif… | 2006 |
| * | K063479 | Arthrex PushlockSummary page 1…Trident Anchor (K0609 14) Versalok Ti Anchor (K(063478) Anthrex Pushlock Anchor (K(063479) Device Classification This device carries an FDA product code MBI and HWC, and is… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K060914.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 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?
VERSALOCK Anchor is indicated for use in the following:
Shoulder: Rotor 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/K100532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100532: Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100532
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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