510(k) Report

510(k) · Cleared

Cleared

Fasterner, Fixation, Biodegradable Soft Tissue

K965228510(k) TraditionalCleared Nov 10, 1997314-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

United States Surgical, A Division of Tyco Healthc · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Nov 10, 1997 after a 314-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
Nov 10, 1997
Review
314 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared2019: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK965228 Fasterner, Fixation, Biodegradable Soft TissueUnited States Surgical, A Division of Tyco Healthc · 1997
  2. Descendant · cites it directly · 7 of its ownK041988 Arthrotek Meniscal Hybrid DeviceBiomet, Inc. · 2004
  3. Descendant · 2 generations on · 6 of its ownK061776 Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  4. Descendant · 3 generations on · 5 of its ownK111564 Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011
  5. Descendant · 4 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
  6. Descendant · 5 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12011: 12015: 12019: 22022: 12025: 1
2004high 2 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all
  • K041988Arthrotek Meniscal Hybrid DeviceBiomet, Inc. · 2004 · cites it directly7descendants
  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006 · 2 generations on6descendants
  • K111564Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011 · 3 generations on5descendants
  • K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 4 generations on2descendants
  • K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K965228Fasterner, Fixation, Biodegradable Soft TissueUnited States Surgical, A Division of Tyco Healthc1997—
+1K041988Arthrotek Meniscal Hybrid DeviceBiomet, Inc.2004—
+2K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc.2006—
+3K111564Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine2011—
+4K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire…T.A.G. Medical Products Corporation, Ltd.2019—
+5K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire…T.A.G. Medical Products Corporation, Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
201110
201510
201920
202210
202510
FIG. 1 — Lineage of K965228, 1997–2025Source: 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), 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 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? (1)

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
*—PDS II Suture, Ethicon, Inc.
Named without a submission number
—

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041988Arthrotek Meniscal Hybrid DeviceBiomet, Inc.20047

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, K041988 (Biomet, Inc., 2004) has gone furthest, with 7 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—

What is it indicated for?

The Surgical Dynamics™ Meniscal Staple** is indicated for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.

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

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K965228 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965228: Fasterner, Fixation, Biodegradable Soft Tissue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965228

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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