510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Acufex Endobutton Tape

K952535510(k) TraditionalCleared Feb 8, 1996252-day reviewClass II21 CFR 878.5000Recalls 2

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

Acufex Microsurgical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Feb 8, 1996 after a 252-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 348 later devices descend from it. It has been recalled 2 times.

Decided
Feb 8, 1996
Review
252 days
Class
Class II
Product code
GAT
Recalls
2
Predicates
0

348 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1998: 1 descendant cleared2019: 28 descendants cleared2011: 8 descendants cleared2024: 35 descendants cleared2013: 10 descendants cleared2009: 3 descendants cleared2008: 5 descendants cleared2005: 4 descendants cleared2015: 11 descendants cleared2004: 2 descendants cleared2003: 1 descendant cleared2007: 2 descendants cleared2006: 3 descendants cleared2010: 1 descendant cleared2012: 4 descendants cleared2018: 15 descendants cleared2017: 18 descendants cleared2020: 24 descendants cleared2025: 32 descendants cleared2014: 18 descendants cleared2021: 24 descendants cleared2022: 26 descendants cleared2026: 37 descendants cleared2023: 27 descendants cleared2016: 8 descendants cleared1995200020052010201520202025
  1. This deviceK952535 Acufex Endobutton TapeAcufex Microsurgical, Inc. · 1996
  2. Descendant · cites it directly · 347 of its ownK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
  3. Descendant · cites it directly · 310 of its ownK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
  4. Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  5. Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  6. Descendant · 2 generations on · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled

Showing 5 of 348 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12003: 12004: 22005: 42006: 32007: 22008: 52009: 32010: 12011: 82012: 42013: 102014: 182015: 112016: 82017: 182018: 152019: 282020: 242021: 242022: 262023: 272024: 352025: 322026: 37
1998high 37 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 348 · See all
  • K980155Endobutton Continuous LoopSmith & Nephew, Inc. · 1998 · cites it directly347descendants
  • K984550Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999 · cites it directly310descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · 2 generations on161descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952535Acufex Endobutton TapeAcufex Microsurgical, Inc.1996—
+1K980155Endobutton Continuous LoopSmith & Nephew, Inc.1998—
+1K984550Pre-Threaded EndobuttonSmith & Nephew, Inc.1999—
+2K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+3K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200310
200420
200540
200630
200720
200850
200930
201010
201180
201240
2013100
2014180
2015110
201680
2017180
2018150
2019280
2020240
2021240
2022260
2023270
2024350
2025320
2026370
FIG. 1 — Lineage of K952535, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GAT? 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 GAT device

  1. #1 K230311 HyperSuturescore 20.2 · 7 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (348)

See all 348

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980155Endobutton Continuous LoopSmith & Nephew, Inc.1998347
K984550Pre-Threaded EndobuttonSmith & Nephew, Inc.1999310

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 11, 2017Class IIZ-1536-2018Employee errorPackaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
Jul 19, 2016Class IIZ-2745-2016Package design/selectionSterility compromised due to breach in sterile packaging

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K980155 (Smith & Nephew, Inc., 1998) has gone furthest, with 347 descendants of its own.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · GAT

2,956in 2025

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, 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
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

More from Acufex Microsurgical, Inc.

78 FDA decisions under this applicant name. See the company

  • K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  • K961853Proline Fast Pass Arthoscopic Needle PasserAcufex Microsurgical, Inc. · 1996
  • K954246Acufex Endofix Absorbable Interference ScrewAcufex Microsurgical, Inc. · 1996
  • K953276Acufex Tag Delivery SystemAcufex Microsurgical, Inc. · 1995
  • K953459Acufex Tag AnchorAcufex Microsurgical, Inc. · 1995

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K952535 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952535: Acufex Endobutton Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952535

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026