510(k) · Cleared
ClearedArthrex SwiveLock Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 21, 2020 as substantially equivalent to K192532 (Arthrex, Inc., 2019) after a 56-day review. Its family tree reaches back 8 generations to 1996. 15 later devices descend from it.
- Decided
- Aug 21, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K961555 (1996). 10 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 4 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 3 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 2 generations backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- 1 generation backK192532 Arthrex SwiveLock AnchorArthrex, Inc. · 2019
- This deviceK201749 Arthrex SwiveLock AnchorArthrex, Inc. · 2020
- Descendant · cites it directly · 13 of its ownK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
- Descendant · 2 generations on · 1 of its ownK233893 AlphaVent Knotless SP PEEK AnchorStryker Endoscopy · 2024
- Descendant · 2 generations on · 1 of its ownK230435 Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K203495Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · cites it directly13descendants
- K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025 · 2 generations on1descendant
- K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy · 2024 · 2 generations on1descendant
- K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. · 2023 · 2 generations on1descendant
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −4 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −3 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −2 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| −1 | K192532 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2019 | — |
| 0 (this device) | K201749 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2020 | — |
| +1 | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | 1 |
| +2 | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025 | — |
| +2 | K233893 | AlphaVent Knotless SP PEEK Anchor | Stryker Endoscopy | 2024 | — |
| +2 | K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex, Inc. | 2023 | — |
| +2 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K192532 | Arthrex SwiveLock AnchorSummary page 4…30: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class Class II Predicate Device K192532: Arthrex SwiveLock Anchor Reference Device(s) K191226: Arthrex SwiveLock Suture Anchor K190728:… | 2019 |
| † | K191226 | Arthrex SwiveLock Suture Anchor | 2019 |
| † | K190728 | Arthrex SwiveLock Anchors | 2019 |
What descends from it? (15)
See all 152 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 24 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K203495 (Arthrex, Inc., 2021) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K192532.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux…
Read the full statement (126 words)
The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/ Tendon Repair, Bunionectomy
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair 7HQQLV (OERZ
• Hip: Capsular Repair, Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201749 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201749: Arthrex SwiveLock Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201749
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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