510(k) · Cleared
ClearedArthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
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 Aug 20, 2015 as substantially equivalent to K101823 (Arthrex, Inc., 2011) and 1 other predicate after a 161-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 20, 2015
- Review
- 161 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K961555 (1996). 13 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- This deviceK150648 Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX…Arthrex, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
- Descendant · cites it directly · 0 of its ownK251750 Trax EX AnchorTrax Surgical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK254188 Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · cites it directly · 0 of its ownK253895 Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025 · cites it directly1descendant
- K251750Trax EX AnchorTrax Surgical, Inc. · 2026 · cites it directly0descendants
- K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026 · 2 generations on0descendants
- K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| 0 (this device) | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock… | Arthrex, Inc. | 2015 | — |
| +1 | K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025 | — |
| +1 | K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026 | — |
| +2 | K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +1 | K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 5…13.5mm Common Name Product Code, Classification Name, CFR : Suture Anchor MBI 21 CFR 888.3030: Smooth or threaded metallic bone fixation fastener Predicate Device : K101823: Arthrex SwivelLock Anchors © K112237: Arthrex MicroSuture Anchors Purpose of Submission Device Description ~ Intended Use T… | 2011 |
| * | K112237 | Microsuture AnchorsSummary page 5…sification Name, CFR : Suture Anchor MBI 21 CFR 888.3030: Smooth or threaded metallic bone fixation fastener Predicate Device : K101823: Arthrex SwivelLock Anchors © K112237: Arthrex MicroSuture Anchors Purpose of Submission Device Description ~ Intended Use This traditional 510(k) premarket notifi… | 2011 |
What descends from it? (4)
3 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 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K252664 (GM Dos Reis Industria e Comercio Ltda., 2025) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K101823.
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. 2015, 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 MicroSuture Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications for use are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral…
Read the full statement (257 words)
The Arthrex MicroSuture Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications for use are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendous at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
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
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 Repairs, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150648: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150648
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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