510(k) · Cleared
ClearedArthroTAK Tendon Anchor Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroTAK, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 2, 2026 as substantially equivalent to K252635 (ArthroTAK, LLC, 2026) and 1 other predicate after a 26-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Sep 2, 2026
- Review
- 26 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K961555 (1996). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 9 generations between
- 3 generations backK253040 Aevumed FASE Suture AnchorAevumed, Inc. · 2025
- 2 generations backK260004 Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
- 1 generation backK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- This deviceK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
Show all 13 generations
- Root · 13 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 12 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 11 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 10 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 9 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 8 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 7 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 6 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 5 generations backK223878 Aevumed RAPID Suture AnchorsAevumed, Inc. · 2023
- 4 generations backK242895 Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 2025
- 3 generations backK253040 Aevumed FASE Suture AnchorAevumed, Inc. · 2025
- 2 generations backK260004 Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
- 1 generation backK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
- This deviceK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −12 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −11 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −10 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −9 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −8 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −7 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −6 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −5 | K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | 2023 | — |
| −4 | K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025 | — |
| −3 | K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025 | — |
| −2 | K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026 | — |
| −1 | K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
| 0 (this device) | K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K252635 | ArthroTAK Tendon Anchor KitSummary page 5…r 888.3040 Product Code(s) MBI | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K252635 ArthroTAK Tendon Anchor Kit MBI K101823 Arthrex SwivelLock Anchors MAI Device Description Summary 21 CFR 807.92(a)(4) The Arthro… | 2026 |
| * | K101823 | Arthrex Swivelock AnchorsSummary page 5…Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K252635 ArthroTAK Tendon Anchor Kit MBI K101823 Arthrex SwivelLock Anchors MAI Device Description Summary 21 CFR 807.92(a)(4) The ArthroTAK Tendon Anchor Kit consists of an Art… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 28 ancestors have a recall of any class.
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. 2026, 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 ArthroTAK Tendon Anchor Kit is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, and elbow 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, Hallux Valgus Reconstruction…
Read the full statement (111 words)
The ArthroTAK Tendon Anchor Kit is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, and elbow 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, 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 llliotibial Band Tenodesis.
-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.
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/K262809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262809: ArthroTAK Tendon Anchor Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262809
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026