510(k) Report

510(k) · Cleared

Cleared

The Surgical Dynamics* S.D. Sorb* E-Z Tac*

K973281510(k) TraditionalCleared Nov 3, 199762-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 3, 1997 as substantially equivalent to K961585 (United States Surgical, A Division of Tyco Healthc, 1996) and 2 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1995.

Decided
Nov 3, 1997
Review
62 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K951658 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1995: 1 other ancestorK951658 · Lactosorb Pop Rivet · Poly-Medics,Inc. · 1995K961585 · Surgical Dynamics Pop Rivet · United States Surgical, A Division of Tyco Healthc · 199619961998
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K961585 · Surgical Dynamics Pop Rivet · United States Surgical, A Division of Tyco Healthc · 1996K951658 · Lactosorb Pop Rivet · Poly-Medics,Inc. · 19950
  1. Root · 2 generations backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
  2. 1 generation backK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
  3. This deviceK973281 The Surgical Dynamics* S.D. Sorb* E-Z Tac*United States Surgical, A Division of Tyco Healthc · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K951658Lactosorb Pop RivetPoly-Medics,Inc.1995—
−1K961585Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc1996—
0 (this device)K973281The Surgical Dynamics* S.D. Sorb* E-Z Tac*United States Surgical, A Division of Tyco Healthc1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
FIG. 1 — Lineage of K973281, 1995–1997Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K961585Surgical Dynamics Pop Rivet
Summary page 1
…NAME: Staple, Fixation, Bone COMMON NAME: Pop Rivet PROPRIETARY NAME: Surgical Dynamics* SeD sorb* E-Z Tac* PREDICATE DEVICES: Surgical Dynamics* SeD sorb* E-Z Tac* (K961 585) Surgical Dynamics* SeD sorb* Suture Anchor (K961578) Mitek Gil Bone Anchor (K953877) DEVICE DESCRIPTION: The Surgical Dynamics*…
United States Surgical, A Division of Tyco Healthc1996—
*K961578Suture Anchor
Summary page 1
…PROPRIETARY NAME: Surgical Dynamics* SeD sorb* E-Z Tac* PREDICATE DEVICES: Surgical Dynamics* SeD sorb* E-Z Tac* (K961 585) Surgical Dynamics* SeD sorb* Suture Anchor (K961578) Mitek Gil Bone Anchor (K953877) DEVICE DESCRIPTION: The Surgical Dynamics* SeD sorb® E-Z Tac® is an absorbable implant to be us…
United States Surgical, A Division of Tyco Healthc1996—
*K953877Mitek Gii Anchor
Summary page 1
…mics* SeD sorb* E-Z Tac* PREDICATE DEVICES: Surgical Dynamics* SeD sorb* E-Z Tac* (K961 585) Surgical Dynamics* SeD sorb* Suture Anchor (K961578) Mitek Gil Bone Anchor (K953877) DEVICE DESCRIPTION: The Surgical Dynamics* SeD sorb® E-Z Tac® is an absorbable implant to be used for affixing soft tissue to b…
Mitek Surgical Products, Inc.1995—

Also cleared against K961585: 1 other device →

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.

What does this lineage say?

  • The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 5 ancestors has a recall.
  • 1 other device also cites its predicate K961585.

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® SeD sorb® E-Z Tac® is indicated for use in soft tissue to bone fixation for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

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

Also cleared against K961585

1 other device cites the same predicate.

  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007

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/K973281 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973281: The Surgical Dynamics* S.D. Sorb* E-Z Tac*.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973281

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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