510(k) Report

510(k) · Cleared

Cleared

Suretac Polyglyconate Absorbable Fixation Device

K911837510(k) TraditionalCleared Nov 15, 1991204-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 Nov 15, 1991 after a 204-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 91 later devices descend from it.

Decided
Nov 15, 1991
Review
204 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

91 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1999: 3 descendants cleared2002: 4 descendants cleared1998: 1 descendant cleared2003: 2 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2001: 2 descendants cleared2009: 6 descendants cleared2008: 1 descendant cleared2010: 3 descendants cleared2011: 3 descendants cleared2005: 1 descendant cleared2017: 7 descendants cleared2018: 4 descendants cleared2023: 8 descendants cleared2012: 2 descendants cleared2013: 4 descendants cleared2019: 6 descendants cleared2026: 2 descendants cleared2020: 5 descendants cleared2016: 1 descendant cleared2014: 3 descendants cleared2015: 2 descendants cleared2022: 4 descendants cleared2021: 4 descendants cleared2025: 8 descendants cleared2024: 3 descendants cleared1990200020102020
  1. This deviceK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
  2. Descendant · cites it directly · 84 of its ownK984490 Sutureless AnchorInnovasive Devices, Inc. · 1999
  3. Descendant · cites it directly · 81 of its ownK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
  4. Descendant · 2 generations on · 80 of its ownK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
  5. Descendant · 2 generations on · 79 of its ownK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
  6. Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

1998: 11999: 32001: 22002: 42003: 22004: 12005: 12006: 12008: 12009: 62010: 32011: 32012: 22013: 42014: 32015: 22016: 12017: 72018: 42019: 62020: 52021: 42022: 42023: 82024: 32025: 82026: 2
1998high 8 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 91 · See all
  • K984490Sutureless AnchorInnovasive Devices, Inc. · 1999 · cites it directly84descendants
  • K973849Bioabsorbable Bankart TackHogan & Hartson · 1998 · cites it directly81descendants
  • K992567Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999 · 2 generations on80descendants
  • K003970Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001 · 2 generations on79descendants
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · cites it directly78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911837Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc.1991—
+1K984490Sutureless AnchorInnovasive Devices, Inc.1999—
+1K973849Bioabsorbable Bankart TackHogan & Hartson1998—
+2K992567Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd.1999—
+2K003970Contour Labral Nail, Model 533520ABionx Implants, Inc.2001—
+1K020056Duet Suture AnchorBionx Implants, Ltd.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199930
200120
200240
200320
200410
200510
200610
200810
200960
201030
201130
201220
201340
201430
201520
201610
201770
201840
201960
202050
202140
202240
202380
202430
202580
202620
FIG. 1 — Lineage of K911837, 1991–2026Source: 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 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
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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? (91)

See all 91

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

NumberDeviceApplicantDecidedDescendants
K984490Sutureless AnchorInnovasive Devices, Inc.199984
K973849Bioabsorbable Bankart TackHogan & Hartson199881
K020056Duet Suture AnchorBionx Implants, Ltd.200278
K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377
K020948Smith & Nephew Suretac - Expanded Indications IISmith & Nephew, Inc.20021
K023417Suretac Iii, Models 7209900, 7209901Smith & Nephew, Inc.20020
K990770Biorc AnchorLinvatec Corp.19990

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, K984490 (Innovasive Devices, Inc., 1999) has gone furthest, with 84 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—

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 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/K911837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911837: Suretac Polyglyconate Absorbable Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911837

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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