510(k) · Cleared
ClearedArthrex Fibertak Suture 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 Aug 13, 2014 as substantially equivalent to K112237 (Arthrex, Inc., 2011) after a 168-day review. Its family tree reaches back 7 generations to 1996. 29 later devices descend from it.
- Decided
- Aug 13, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K961555 (1996). 10 ancestors in all. 29 later devices descend from it, 2 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 backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 1 generation backK112237 Microsuture AnchorsArthrex, Inc. · 2011
- This deviceK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
- Descendant · cites it directly · 27 of its ownK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
- Descendant · 2 generations on · 24 of its ownK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
- Descendant · 3 generations on · 17 of its ownK200341 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- Descendant · 4 generations on · 16 of its ownK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- Descendant · 5 generations on · 6 of its ownK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K151230Arthrex FiberTak AnchorsArthrex, Inc. · 2015 · cites it directly27descendants
- K181769Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018 · 2 generations on24descendants
- K200341Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 3 generations on17descendants
- K203268Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 4 generations on16descendants
- K230568FiberTak Suture AnchorArthrex, Inc. · 2023 · 5 generations on6descendants
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 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −1 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
| +1 | K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | 2015 | — |
| +2 | K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018 | — |
| +3 | K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| +4 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| +5 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K112237 | Microsuture AnchorsSummary page 4…CFR Fastener, fixation, nondegradable, soft tissue 21 CFR 888.3040 Predicate Device K112237: Arthrex MicroSuture Anchor This traditional 510(k) premarket notification is submitted… | 2011 |
What descends from it? (29)
See all 292 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 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K151230 (Arthrex, Inc., 2015) has gone furthest, with 27 descendants of its own.
- 6 other devices also cite its predicate K112237.
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. 2014, 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 FiberTak Suture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications 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…
Read the full statement (135 words)
The Arthrex FiberTak Suture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications 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 Tendons 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140476: Arthrex Fibertak Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140476
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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