510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Acufex T-Bar

K925573510(k) TraditionalCleared May 5, 1993183-day reviewClass II21 CFR 888.1100Recalls 1

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

Acufex Microsurgical, Inc. · HRX Arthroscope

Cleared on May 5, 1993 after a 183-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. It has been recalled once.

Decided
May 5, 1993
Review
183 days
Class
Class II
Product code
HRX
Recalls
1
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 deviceK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993
  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)K925573Acufex T-BarAcufex Microsurgical, Inc.1993—
+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 K925573, 1993–2026Source: 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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 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? (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)

Recalls of this device

DateClassRecallRoot causeReason
Jun 24, 2020Class IIZ-2702-2020Process designThe T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

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 HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

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

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The HRX category page

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https://510kreport.com/device/K925573 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925573: Acufex T-Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925573

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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