510(k) Report

510(k) · Cleared

Cleared

Arthrex FiberTak Suture Anchor

K251809510(k) TraditionalCleared Jul 18, 202536-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 18, 2025 as substantially equivalent to K181769 (Arthrex, Inc., 2018) and 1 other predicate after a 36-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.

Decided
Jul 18, 2025
Review
36 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
2

Its longest line of descent runs back 10 generations to K961555 (1996). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 2 other ancestors2014: 1 other ancestor2007: 3 other ancestors2013: 1 other ancestor2011: 2 other ancestors2008: 1 other ancestor2006: 3 other ancestors2005: 2 other ancestors1998: 1 other ancestor2001: 1 other ancestor2004: 1 other ancestor2026: 1 descendant clearedK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K061863 · Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family · Arthrex, Inc. · 2006K071177 · Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew · Arthrex, Inc. · 2007K091844 · Arthrex Bio-Composite Suturetak Anchors · Arthrex, Inc. · 2009K112237 · Microsuture Anchors · Arthrex, Inc. · 2011K140476 · Arthrex Fibertak Suture Anchor · Arthrex, Inc. · 2014K151230 · Arthrex FiberTak Anchors · Arthrex, Inc. · 2015K181769 · Arthrex FiberTak Suture Anchor · Arthrex, Inc. · 20181995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 6 other ancestors4 generations back: 2 other ancestors5 generations back: 3 other ancestors6 generations back: 2 other ancestors7 generations back: 1 other ancestor 1 generation forward: 1 descendant K181769 · Arthrex FiberTak Suture Anchor · Arthrex, Inc. · 2018K151230 · Arthrex FiberTak Anchors · Arthrex, Inc. · 2015K140476 · Arthrex Fibertak Suture Anchor · Arthrex, Inc. · 2014K112237 · Microsuture Anchors · Arthrex, Inc. · 2011K091844 · Arthrex Bio-Composite Suturetak Anchors · Arthrex, Inc. · 2009K071177 · Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew · Arthrex, Inc. · 2007K061863 · Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family · Arthrex, Inc. · 2006K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996−10−50
  1. Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 6 generations between
  3. 3 generations backK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
  4. 2 generations backK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
  5. 1 generation backK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
  6. This deviceK251809 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025
  7. Descendant · cites it directly · 0 of its ownK260561 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2026
Show all 10 generations
  1. Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 7 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. 6 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
  6. 5 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
  7. 4 generations backK112237 Microsuture AnchorsArthrex, Inc. · 2011
  8. 3 generations backK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
  9. 2 generations backK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
  10. 1 generation backK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
  11. This deviceK251809 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K260561Arthrex FiberTak Suture AnchorArthrex, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−9K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−8K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−7K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
−6K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…Arthrex, Inc.2007—
−5K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009—
−4K112237Microsuture AnchorsArthrex, Inc.2011—
−3K140476Arthrex Fibertak Suture AnchorArthrex, Inc.2014—
−2K151230Arthrex FiberTak AnchorsArthrex, Inc.2015—
−1K181769Arthrex FiberTak Suture AnchorArthrex, Inc.2018—
0 (this device)K251809Arthrex FiberTak Suture AnchorArthrex, Inc.2025—
+1K260561Arthrex FiberTak Suture AnchorArthrex, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200410
200520
200630
200730
200810
201120
201310
201410
201820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K251809, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K181769Arthrex FiberTak Suture Anchor
Summary page 5
…21 CFR 888.3040: Fastener, Fixation, Nondegradable, Soft- Tissue Regulatory Class Class II Primary Predicate Device K181769: Arthrex FiberTak Suture Anchor Additional Predicate Device N/A Reference Device K181746: Smith & Nephew Microrapt…
Arthrex, Inc.2018—
*K181746MICRORAPTOR Knotless Suture Anchor
Summary page 5
…ulatory Class Class II Primary Predicate Device K181769: Arthrex FiberTak Suture Anchor Additional Predicate Device N/A Reference Device K181746: Smith & Nephew Microraptor Knotless Suture Anchor Purpose of Submission This Traditional 5…
Smith and Nephew, Inc.2018—

Also cleared against K181769: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260

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 29 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 9 of the 28 ancestors have a recall of any class.
  • Of its descendants, K260561 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K181769.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip the following procedures: * 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 (146 words)

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip the following procedures:

* 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

* Hip: Acetabular Labral Repair and Reconstruction

Indications for use as stated in the FDA summary.

Also cleared against K181769

5 other devices cite the same predicate.

  • K254306Aevumed FENIX Suture AnchorAevumed, Inc. · 2026
  • K202444Knotless TensionTight Button Implant SystemArthrex, Inc. · 2020
  • K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd. · 2020
  • K200341Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
  • K191426FiberTak ButtonArthrex, Inc. · 2019

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K251809 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251809: 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/K251809

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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