510(k) · Cleared
ClearedArthrex SwiveLock Anchors
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 Mar 24, 2016 as substantially equivalent to K101823 (Arthrex, Inc., 2011) and 1 other predicate after a 310-day review. Its family tree reaches back 7 generations to 1997. 38 later devices descend from it.
- Decided
- Mar 24, 2016
- Review
- 310 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971358 (1997). 29 ancestors in all, the oldest K915424 (1993). 38 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 3 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 2 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 1 generation backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- This deviceK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · cites it directly · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · cites it directly · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · 2 generations on · 21 of its ownK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- Descendant · 3 generations on · 13 of its ownK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- Descendant · cites it directly · 8 of its ownK173845 Arthrex SwiveLockArthrex, Inc. · 2018
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · cites it directly29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · cites it directly28descendants
- K191226Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019 · 2 generations on21descendants
- K203495Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · 3 generations on13descendants
- K173845Arthrex SwiveLockArthrex, Inc. · 2018 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −6 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −3 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −2 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −1 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +1 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +1 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +2 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| +3 | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | 1 |
| +1 | K173845 | Arthrex SwiveLock | Arthrex, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K101823 | Arthrex Swivelock AnchorsSummary page 4…ation Name, CFR 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Predicate Device K101823: Arthrex SwiveLock Anchors K071176: Arthrex Bio Interference Screws Purpose of Submission Thi… | 2011 |
| * | K071176 | Modification to: Arthrex Interference ScrewSummary page 4…tallic bone fixation appliances and accessories Predicate Device K101823: Arthrex SwiveLock Anchors K071176: Arthrex Bio Interference Screws Purpose of Submission This traditional 510(k) premarket notification is submitted to incl… | 2007 |
What descends from it? (38)
See all 385 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 19 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K171141 (Arthrex, Inc., 2017) has gone furthest, with 29 descendants of its own.
- 13 other devices also cite its predicate K101823.
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. 2016, 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 anchors are 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 (138 words)
The Arthrex SwiveLock anchors are 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 and Bunionectomy.
* Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior
Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75
— 5.5 SwiveLock only).
* Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
* Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction,
Lateral Epicondylitis repair.
* Hip: Capsular repair, acetabular labral repair
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151342: Arthrex SwiveLock Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151342
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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