510(k) Report

510(k) · Cleared

Cleared

Acufex Endobutton System

K933948510(k) TraditionalCleared Jul 21, 1994343-day reviewClass II21 CFR 888.3030

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

Acufex Microsurgical, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jul 21, 1994 after a 343-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 317 later devices descend from it.

Decided
Jul 21, 1994
Review
343 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1999: 1 descendant cleared2013: 8 descendants cleared2002: 1 descendant cleared2005: 3 descendants cleared2009: 5 descendants cleared2004: 2 descendants cleared2008: 4 descendants cleared2006: 2 descendants cleared2018: 15 descendants cleared2019: 26 descendants cleared2017: 15 descendants cleared2011: 5 descendants cleared2020: 22 descendants cleared2024: 35 descendants cleared2025: 30 descendants cleared2015: 9 descendants cleared2014: 18 descendants cleared2021: 22 descendants cleared2012: 3 descendants cleared2022: 22 descendants cleared2026: 34 descendants cleared2016: 6 descendants cleared2023: 26 descendants cleared2007: 2 descendants cleared1990200020102020
  1. This deviceK933948 Acufex Endobutton SystemAcufex Microsurgical, Inc. · 1994
  2. Descendant · cites it directly · 310 of its ownK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
  3. Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  4. Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  5. Descendant · 2 generations on · 97 of its ownK033838 Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · Recalled
  6. Descendant · 3 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled

Showing 5 of 317 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12002: 12004: 22005: 32006: 22007: 22008: 42009: 52011: 52012: 32013: 82014: 182015: 92016: 62017: 152018: 152019: 262020: 222021: 222022: 222023: 262024: 352025: 302026: 34
1998high 35 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 317 · See all
  • 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
  • K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · 2 generations on97descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 3 generations on94descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933948Acufex Endobutton SystemAcufex Microsurgical, Inc.1994—
+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—
+2K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc.20041
+3K083070Toggleloc SystemBiomet Sports Medicine20086

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200420
200530
200620
200720
200840
200950
201150
201230
201380
2014180
201590
201660
2017150
2018150
2019260
2020220
2021220
2022220
2023260
2024350
2025300
2026340
FIG. 1 — Lineage of K933948, 1994–2026Source: 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 MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (317)

See all 317

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

NumberDeviceApplicantDecidedDescendants
K984550Pre-Threaded EndobuttonSmith & Nephew, Inc.1999310
K974341Mitek BTB Absorbable (Pla) Cross PinMitek Products19985

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?

  • Of its descendants, K984550 (Smith & Nephew, Inc., 1999) has gone furthest, with 310 descendants of its own.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

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
  • K952535Acufex Endobutton TapeAcufex Microsurgical, Inc. · 19962 recalls
  • K953276Acufex Tag Delivery SystemAcufex Microsurgical, Inc. · 1995

Recent decisions in MAI

The MAI category page

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  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K933948 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933948: Acufex Endobutton System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933948

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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