510(k) Report

510(k) · Cleared

Cleared

Acufex T-Fix Delivery System

K942442510(k) TraditionalCleared Dec 5, 1994196-day reviewClass II21 CFR 868.5150

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

Acufex Microsurgical, Inc. · MIA Needle, Spinal, Short Term

Cleared on Dec 5, 1994 after a 196-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 39 later devices descend from it.

Decided
Dec 5, 1994
Review
196 days
Class
Class II
Product code
MIA
Recalls
None
Predicates
0

39 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2000: 1 descendant cleared2001: 2 descendants cleared2002: 1 descendant cleared2007: 2 descendants cleared2010: 2 descendants cleared2004: 2 descendants cleared1999: 1 descendant cleared1998: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2008: 2 descendants cleared2018: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2020: 1 descendant cleared2022: 3 descendants cleared2015: 1 descendant cleared2023: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants cleared2017: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK942442 Acufex T-Fix Delivery SystemAcufex Microsurgical, Inc. · 1994
  2. Descendant · cites it directly · 30 of its ownK002261 MR-IIISmith & Nephew, Inc. · 2000
  3. Descendant · 2 generations on · 17 of its ownK092508 Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse…Smith & Nephew, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 16 of its ownK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 15 of its ownK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
  6. Descendant · 3 generations on · 12 of its ownK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

1996: 11998: 11999: 12000: 12001: 22002: 12004: 22007: 22008: 22009: 12010: 22012: 12013: 22014: 12015: 12016: 22017: 12018: 12019: 12020: 12021: 12022: 32023: 32024: 12025: 22026: 2
1996high 3 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 39 · See all
  • K002261MR-IIISmith & Nephew, Inc. · 2000 · cites it directly30descendants
  • K092508Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Smith & Nephew, Inc. · 2010 · 2 generations on17descendants
  • K020480RBMSmith & Nephew, Inc. · 2002 · 2 generations on16descendants
  • K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007 · 2 generations on15descendants
  • K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc. · 2012 · 3 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942442Acufex T-Fix Delivery SystemAcufex Microsurgical, Inc.1994—
+1K002261MR-IIISmith & Nephew, Inc.2000—
+2K092508Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix…Smith & Nephew, Inc.20103
+2K020480RBMSmith & Nephew, Inc.20021
+2K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc.2007—
+3K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra…Smith & Nephew, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
200010
200120
200210
200420
200720
200820
200910
201020
201210
201320
201410
201510
201620
201710
201810
201910
202010
202110
202230
202330
202410
202520
202620
FIG. 1 — Lineage of K942442, 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 MIA? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K002261MR-IIISmith & Nephew, Inc.200030
K955768Biofix Biodegradable Meniscus Arrow SystemBioscience, Inc.19966
K012342Ams Soft-Tissue Approximation SystemAmerican Medical Systems, Inc.20010

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, K002261 (Smith & Nephew, Inc., 2000) has gone furthest, with 30 descendants of its own.

How does its category compare?

All MIA devices

MIA Needle, Spinal, Short Term: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIA

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MIA

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

Recalls per year · MIA

No recall names MIA since 2007.

Adverse event reports per year · MIA

14in 2025

2007: 52008: 62009: 42010: 12012: 32013: 22014: 42015: 122016: 232017: 152018: 142019: 92020: 52021: 42022: 192023: 122024: 232025: 14
2007high 23 (2016) · low 0 (2011)2025

MAUDE reports naming product code MIA, 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—05
20080—06
20090—04
20100—01
20110—00
20120—03
20130—02
20140—04
20150—012
20160—023
20170—015
20181—014
20190—09
20200—05
20210—04
20220—019
20230—012
20240—023
20250—014
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 MIA

The MIA category page

  • K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™…Smiths Medical Asd, Inc. · 2018
  • K051860Flexible Introducer Cannula, Model 135-1837Epimed International, Inc. · 2005
  • K983858Spinal Anesthesia Needles and Introducer NeedlesSims Portex, Inc. · 1999
  • K982269Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GAAllegiance Healthcare Corp. · 1998
  • K971645Reganes Spinal Needle (Various)Avid N.I.T., Inc. · 1997

https://510kreport.com/device/K942442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942442: Acufex T-Fix Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942442

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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