510(k) Report

510(k) · Cleared

Cleared

Knotless Fibertak Suture Anchor

K130458510(k) TraditionalCleared May 3, 201370-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 May 3, 2013 as substantially equivalent to K120155 (Arthrex, Inc., 2012) and 2 other predicates after a 70-day review. Its family tree reaches back 5 generations to 1999. 2 later devices descend from it.

Decided
May 3, 2013
Review
70 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K990088 (1999). 29 ancestors in all, the oldest K813581 (1982). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors2001: 3 other ancestors2000: 4 other ancestors1997: 2 other ancestors1982: 1 other ancestor2003: 1 other ancestor1998: 1 other ancestor1996: 3 other ancestors1993: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor2025: 1 descendant cleared2026: 1 descendant clearedK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K032245 · Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237, AR-7238, AR-7239 · Arthrex, Inc. · 2004K041553 · Arthrex Suture Grafting Kit · Arthrex, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 5 other ancestors4 generations back: 7 other ancestors5 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K041553 · Arthrex Suture Grafting Kit · Arthrex, Inc. · 2004K032245 · Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237, AR-7238, AR-7239 · Arthrex, Inc. · 2004K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999−50
  1. Root · 5 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 4 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 3 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. 2 generations backK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
  5. 1 generation backK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
  6. This deviceK130458 Knotless Fibertak Suture AnchorArthrex, Inc. · 2013
  7. Descendant · cites it directly · 1 of its ownK252596 Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 2025
  8. Descendant · 2 generations on · 0 of its ownK260921 Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture…Tigon Medical · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 2025 · cites it directly1descendant
  • K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−4K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−3K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
−2K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape…Arthrex, Inc.2004—
−1K041553Arthrex Suture Grafting KitArthrex, Inc.2004—
0 (this device)K130458Knotless Fibertak Suture AnchorArthrex, Inc.2013—
+1K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical2025—
+2K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199010
199310
199410
199510
199630
199720
199810
200040
200130
200310
200620
200710
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
202610
FIG. 1 — Lineage of K130458, 1999–2026Source: 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? (3)

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
*K120155Arthrex Knotless Suturetak Anchor
Summary page 1
…Fastener, fixation, nondegradable, softtissue CFR 21ICFRS88.3040 Predicate Device K120 155: Aribrex Knodless Suture Tac K(04 1553: Arthrex FiberWire…
Arthrex, Inc.2012—
*K041553Arthrex Suture Grafting KitArthrex, Inc.2004—
*K110145Biomet Sports Medicine Juggerknot Soft Anchor
Summary page 1
…5: Aribrex Knodless Suture Tac K(04 1553: Arthrex FiberWire 1(110145 Biornet JuggerKnoiT MVSoft Anchors Purposeof Submission This traditional 510(k) premarket notification is…
Biomet, Inc.20113

Also cleared against K120155: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251

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 14 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 5 of the 29 ancestors have a recall of any class.
  • Of its descendants, K252596 (Tigon Medical, 2025) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K120155.

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. 2013, 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 Knotless Fiber Tak Suture Anchor is intended for sutur or tissue fixation in the foot, ankle, knee, hand, wrist. elbow, shoulder, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reatachmrent, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromi-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral…

Read the full statement (133 words)

The Arthrex Knotless Fiber Tak Suture Anchor is intended for sutur or tissue fixation in the foot, ankle, knee, hand, wrist. elbow, shoulder, and hip. Specific indications are listed below:

Elbow: Biceps Tendon Reatachmrent, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromi-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstructions. 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, Iliotibial Band Tenodesis

Hip: Acetabular Labral repair

Indications for use as stated in the FDA summary.

Also cleared against K120155

1 other device cites the same predicate.

  • K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc. · 2023

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/K130458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130458: Knotless 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/K130458

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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