510(k) Report

510(k) · Cleared

Cleared

Acufex Tag Bioabsorbable Anchors

K961555510(k) TraditionalCleared Jul 10, 199679-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. · JDR Staple, Fixation, Bone

Cleared on Jul 10, 1996 after a 79-day review. The FDA summary names its predicate without a number. 584 later devices descend from it.

Decided
Jul 10, 1996
Review
79 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 2 descendants cleared1998: 2 descendants cleared2006: 6 descendants cleared2010: 16 descendants cleared2015: 22 descendants cleared2002: 4 descendants cleared2004: 2 descendants cleared2007: 12 descendants cleared2008: 9 descendants cleared2013: 30 descendants cleared2011: 29 descendants cleared2012: 18 descendants cleared2009: 17 descendants cleared2022: 27 descendants cleared2014: 32 descendants cleared2017: 23 descendants cleared1999: 2 descendants cleared2005: 1 descendant cleared2019: 27 descendants cleared2023: 61 descendants cleared2025: 52 descendants cleared2020: 38 descendants cleared2016: 16 descendants cleared2018: 24 descendants cleared2026: 44 descendants cleared2021: 25 descendants cleared2024: 43 descendants cleared1995200020052010201520202025
  1. This deviceK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. Descendant · cites it directly · 478 of its ownK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 477 of its ownK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. Descendant · 3 generations on · 283 of its ownK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. Descendant · 4 generations on · 227 of its ownK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
  6. Descendant · cites it directly · 166 of its ownK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998

Showing 5 of 584 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22002: 42003: 22004: 22005: 12006: 62007: 122008: 92009: 172010: 162011: 292012: 182013: 302014: 322015: 222016: 162017: 232018: 242019: 272020: 382021: 252022: 272023: 612024: 432025: 522026: 44
1998high 61 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 584 · See all
  • K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · cites it directly478descendants
  • K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc. · 2006 · 2 generations on477descendants
  • K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006 · 3 generations on283descendants
  • K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2007 · 4 generations on227descendants
  • K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998 · cites it directly166descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
+1K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
+2K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
+3K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
+4K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…Arthrex, Inc.2007—
+1K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200240
200320
200420
200510
200660
2007120
200890
2009170
2010160
2011290
2012180
2013300
2014320
2015220
2016160
2017230
2018240
2019270
2020380
2021250
2022270
2023610
2024430
2025520
2026440
FIG. 1 — Lineage of K961555, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Acufex TAG Anchors (non-absorbable)
Named without a submission number
—
*—Mitek Mini GII Anchors
Named without a submission number
—

What descends from it? (584)

See all 584

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

NumberDeviceApplicantDecidedDescendants
K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.2003478
K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166

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, K031685 (Smith & Nephew, Inc., 2003) has gone furthest, with 478 descendants of its own.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue.

The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow. These additional indications employ the following screw types and sizes:

Size/Style — Indication

3.7mm Rod II — Foot, ankle, elbow

3.7mm Wedge — Foot, ankle, elbow

3.0mm Wedge — Foot, ankle, elbow

3.0mm Wedge Mini-TAG — Foot, ankle

2.0mm Wedge Mini-TAG — Foot, ankle

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Acufex Microsurgical, Inc.

78 FDA decisions under this applicant name. See the company

  • 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
  • K953459Acufex Tag AnchorAcufex Microsurgical, Inc. · 1995

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K961555 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961555: Acufex Tag Bioabsorbable Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961555

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026