510(k) · Cleared
Recalled · Class II · 2017Arthrex 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 Jan 7, 2011 as substantially equivalent to K082810 (Arthrex, Inc., 2009) and 2 other predicates after a 191-day review. Its family tree reaches back 6 generations to 1996. 103 later devices descend from it. It has been recalled 6 times.
- Decided
- Jan 7, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961555 (1996). 8 ancestors in all. 103 later devices descend from it, 14 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 2 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 1 generation backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- This deviceK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011
- Descendant · cites it directly · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- Descendant · cites it directly · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 2 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · 2 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · 2 generations on · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · cites it directly40descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · cites it directly38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 2 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 2 generations on28descendants
- K133671Iconix All Suture AnchorsStryker Corp. · 2014 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −2 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −1 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| 0 (this device) | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | — |
| +1 | K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | Smith & Nephew, Inc. | 2011 | — |
| +1 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +2 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +2 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +2 | K133671 | Iconix All Suture Anchors | Stryker Corp. | 2014 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 15 | 0 |
| 2024 | 11 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 1…1 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories. Predicate Device K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corkscrew Suture… | 2009 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…bone fixation appliances and accessories. Predicate Device K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors… | 2006 |
| * | K051726 | Arthrex Tenodesis FamilySummary page 1…K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors K051726: Arthrex Tenodesis Family Device Descriptionand Intended The Swiveock Anchor isa two-component knotless… | 2005 |
What descends from it? (103)
See all 10314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | 2011 | 40 |
| K151342 | Arthrex SwiveLock Anchors | 2016 | 38 |
| K192532 | Arthrex SwiveLock Anchor | 2019 | 16 |
| K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | 2015 | 10 |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture… | 2015 | 4 |
| K131635 | Rotation Medical Bone Staple (RMB Staple) | 2013 | 3 |
| K173269 | KATOR Suture Anchor | 2018 | 2 |
| K252664 | GMReis Suture Anchors | 2025 | 1 |
| K262809 | ArthroTAK Tendon Anchor Kit | 2026 | 0 |
| K260018 | Arthrex FiberButton | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2017 | Class II | Z-2041-2017 | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. |
| Mar 24, 2017 | Class II | Z-2043-2017 | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. |
| Mar 24, 2017 | Class II | Z-2044-2017 | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. |
| Mar 24, 2017 | Class II | Z-2042-2017 | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. |
| Mar 24, 2017 | Class II | Z-2046-2017 | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. |
| Mar 24, 2017 | Class II | Z-2045-2017 | Under Investigation by firm | Some eyelets broke from SwiveLock Anchor on insertion. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K110545 (Smith & Nephew, Inc., 2011) has gone furthest, with 40 descendants of its own.
- 12 other devices also cite its predicate K082810.
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. 2011, 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 Repairs, 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 (121 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 Repairs, 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.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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 as stated in the FDA summary.
https://510kreport.com/device/K101823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101823: 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/K101823
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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