510(k) · Cleared
ClearedArthrex Knotless Suturetak Anchor
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 Feb 17, 2012 as substantially equivalent to K061863 (Arthrex, Inc., 2006) after a 30-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 17, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961555 (1996). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 1 generation backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- This deviceK120155 Arthrex Knotless Suturetak AnchorArthrex, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK130458 Knotless Fibertak Suture AnchorArthrex, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK252596 Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 2025
- Descendant · 3 generations on · 0 of its ownK260921 Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture…Tigon Medical · 2026
- Descendant · cites it directly · 0 of its ownK232340 Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K130458Knotless Fibertak Suture AnchorArthrex, Inc. · 2013 · cites it directly2descendants
- K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 2025 · 2 generations on1descendant
- K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical · 2026 · 3 generations on0descendants
- K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −3 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −2 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −1 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K120155 | Arthrex Knotless Suturetak Anchor | Arthrex, Inc. | 2012 | — |
| +1 | K130458 | Knotless Fibertak Suture Anchor | Arthrex, Inc. | 2013 | — |
| +2 | K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025 | — |
| +3 | K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026 | — |
| +1 | K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…OAT - 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture Predicate Devices K061863 Arthrex 3 mm PEEKSut ureTak Device Description and The Art/irex Knotless SutureTak Anchor is a tap-in ribbed Intende… | 2006 |
What descends from it? (4)
2 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 16 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K130458 (Arthrex, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 33 other devices also cite its predicate K061863.
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. 2012, 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 Artlirex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the -foot, ankde, knee, hand, wrist, elbow, shoulder, and hip., Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acmomio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral…
Read the full statement (136 words)
The Artlirex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the -foot, ankde, knee, hand, wrist, elbow, shoulder, and hip., Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acmomio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstnuctions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
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, fliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labial repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120155 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120155: Arthrex Knotless Suturetak Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120155
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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