510(k) · Cleared
Recalled · Class II · 2021Arthrex 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 Apr 19, 2021 as substantially equivalent to K191226 (Arthrex, Inc., 2019) and 1 other predicate after a 143-day review. Its family tree reaches back 11 generations to 1979. 13 later devices descend from it. It has been recalled once.
- Decided
- Apr 19, 2021
- Review
- 143 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 11 generations to K792022 (1979). 91 ancestors in all. 13 later devices descend from it, 11 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 2 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 1 generation backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- This deviceK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
- Descendant · cites it directly · 1 of its ownK233893 AlphaVent Knotless SP PEEK AnchorStryker Endoscopy · 2024
- Descendant · cites it directly · 1 of its ownK230435 Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260405 FiberTape ButtonArthrex, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 4 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 3 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 2 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 1 generation backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- This deviceK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025 · cites it directly1descendant
- K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy · 2024 · cites it directly1descendant
- K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. · 2023 · cites it directly1descendant
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · cites it directly1descendant
- K260405FiberTape ButtonArthrex, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −4 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −3 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −2 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| −1 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| 0 (this device) | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | — |
| +1 | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025 | — |
| +1 | K233893 | AlphaVent Knotless SP PEEK Anchor | Stryker Endoscopy | 2024 | — |
| +1 | K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex, Inc. | 2023 | — |
| +1 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
| +1 | K260405 | FiberTape Button | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 K253931 Arthrex Bioabsorbable PushLock Suture Anchorsscore 17.1 · 10 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 |
|---|---|---|---|
| * | K191226 | Arthrex SwiveLock Suture AnchorSummary page 5…1 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Predicate Device(s) K191226: Arthrex SwiveLock Suture Anchor K201749: Arthrex SwiveLock Anchor Reference Device(s) K173240: Art… | 2019 |
| * | K201749 | Arthrex SwiveLock AnchorSummary page 5…ppliances and accessories Regulatory Class II Predicate Device(s) K191226: Arthrex SwiveLock Suture Anchor K201749: Arthrex SwiveLock Anchor Reference Device(s) K173240: Arthrex PushLock K173845: Arthrex SwiveLock… | 2020 |
| † | K173240 | Arthrex PushLock | 2018 |
| † | K173845 | Arthrex SwiveLock | 2018 |
| † | K190728 | Arthrex SwiveLock Anchors | 2019 |
| † | K192441 | Arthrex SwiveLock Anchors | 2019 |
| † | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | 2015 |
What descends from it? (13)
See all 1311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243712 | WasherCap™ Mini Fixation System (Model 45) | 2025 | 1 |
| K233893 | AlphaVent Knotless SP PEEK Anchor | 2024 | 1 |
| K230435 | Arthrex 3.9 mm SwiveLock Anchor | 2023 | 1 |
| K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | 2021 | 1 |
| K260405 | FiberTape Button | 2026 | 0 |
| K253538 | TeKBrace Knotless Anchor | 2026 | 0 |
| K253695 | LigaMend | 2026 | 0 |
| K250528 | Stryker AlphaVent™ Knotless SP Biocomposite Anchor | 2025 | 0 |
| K243988 | RootMend MRR | 2025 | 0 |
| K231093 | AlphaVent Suture Anchors | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2021 | Class II | Z-2107-2021 | Under Investigation by firm | Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 91 ancestors have a recall of any class.
- Of its descendants, K243712 (Abanza Tecnomed S.L, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K191226.
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. 2021, 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 skeletally mature pediatric and adult patients for the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction. Foot/Ankle…
Read the full statement (185 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 skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulo labral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy
Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only)
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair
Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203495: Arthrex SwiveLock Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203495
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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