510(k) · Cleared
ClearedArthrex Knotless SutureTak Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 16, 2017 as substantially equivalent to K063478 (Depuy Mitek, A Johnson & Johnson Company, 2006) after a 41-day review. Its family tree reaches back 4 generations to 2001. 27 later devices descend from it.
- Decided
- May 16, 2017
- Review
- 41 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K012125 (2001). 8 ancestors in all, the oldest K971723 (1997). 27 later devices descend from it, 4 citing it directly.
- 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 deviceK171020 Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017
- Descendant · cites it directly · 16 of its ownK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
- Descendant · 3 generations on · 5 of its ownK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- Descendant · 2 generations on · 5 of its ownK231113 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2023
- Descendant · 4 generations on · 4 of its ownK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K203268Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · cites it directly16descendants
- K230568FiberTak Suture AnchorArthrex, Inc. · 2023 · 2 generations on6descendants
- K231330FiberTak® Suture AnchorArthrex, Inc. · 2023 · 3 generations on5descendants
- K231113Arthrex FiberTak Suture AnchorArthrex, Inc. · 2023 · 2 generations on5descendants
- K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023 · 4 generations on4descendants
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) | K171020 | Arthrex Knotless SutureTak Anchor | Arthrex, Inc. | 2017 | — |
| +1 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| +2 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
| +3 | K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | 2023 | — |
| +2 | K231113 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
| +4 | K232973 | Arthrex Knee FiberTak® Button 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Summary page 3…Anchor Product Code MBI Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K063478: DePUY Mitek VERSALOK Anchor Purpose of This traditional 510(k) premarket notification is submitted to obtain knee joi… | 2006 |
What descends from it? (27)
See all 274 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K203268 (Arthrex, Inc., 2020) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K063478.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral…
Read the full statement (139 words)
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
Hip: Capsular Repair, Acetabular Labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171020: Arthrex Knotless SutureTak Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171020
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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