510(k) Report

510(k) · Cleared

Cleared

Acufex Rotator Cuff Fixation Button

K941740510(k) TraditionalCleared Jun 30, 1995449-day reviewClass I21 CFR 878.4930

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

Acufex Microsurgical, Inc. · KGS Retention Device, Suture

Cleared on Jun 30, 1995 after a 449-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 30, 1995
Review
449 days
Class
Class I
Product code
KGS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K941740Source: FDA 510(k) database · 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 KGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All KGS devices

KGS Retention Device, Suture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGS

FDA has decided no KGS device since 2007.

Median 510(k) review, days · KGS

Too few KGS 510(k)s in any year since 2007 to give a median.

Recalls per year · KGS

No recall names KGS since 2007.

Adverse event reports per year · KGS

3in 2025

2007: 262008: 152009: 62010: 12011: 12012: 42013: 62014: 22015: 12016: 12017: 42019: 12020: 32021: 12023: 112024: 22025: 3
2007high 26 (2007) · low 0 (2018)2025

MAUDE reports naming product code KGS, 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
20070—026
20080—015
20090—06
20100—01
20110—01
20120—04
20130—06
20140—02
20150—01
20160—01
20170—04
20180—00
20190—01
20200—03
20210—01
20220—00
20230—011
20240—02
20250—03
20260—0—

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 KGS

The KGS category page

  • K030031Soft Tissue Anchoring WashersAccu-Speed, Incorporated · 2003
  • K020480RBMSmith & Nephew, Inc. · 20021 recall
  • K964935Suture LockSmith & Nephew Endoscopy, Inc. · 1997
  • K930675Mitek Cone WasherMitek Surgical Products, Inc. · 1993
  • K904435Ventrofil Tension Relief Suture SetAesculap, Inc. · 1991

https://510kreport.com/device/K941740 · printed Nov 4, 2026

Cite this page

510(k) Report. “K941740: Acufex Rotator Cuff Fixation Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K941740

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