510(k) Report

510(k) · Cleared

Cleared

Cruciate Ligament Button

K813581510(k) TraditionalCleared Mar 23, 198285-day reviewClass I21 CFR 878.4930

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

Biomet, Inc. · KGS Retention Device, Suture

Cleared on Mar 23, 1982 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 149 later devices descend from it.

Decided
Mar 23, 1982
Review
85 days
Class
Class I
Product code
KGS
Recalls
None
Predicates
0

149 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2004: 2 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2017: 7 descendants cleared2011: 3 descendants cleared2020: 13 descendants cleared2013: 10 descendants cleared2019: 10 descendants cleared2015: 5 descendants cleared2016: 5 descendants cleared2014: 8 descendants cleared2012: 2 descendants cleared2023: 16 descendants cleared2018: 4 descendants cleared2026: 13 descendants cleared2022: 6 descendants cleared2021: 13 descendants cleared2025: 13 descendants cleared2024: 14 descendants cleared19801990200020102020
  1. This deviceK813581 Cruciate Ligament ButtonBiomet, Inc. · 1982
  2. Descendant · cites it directly · 142 of its ownK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
  3. Descendant · cites it directly · 97 of its ownK033838 Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
  5. Descendant · 2 generations on · 83 of its ownK110145 Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 52 of its ownK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

2004: 22006: 12007: 12008: 22010: 12011: 32012: 22013: 102014: 82015: 52016: 52017: 72018: 42019: 102020: 132021: 132022: 62023: 162024: 142025: 132026: 13
2004high 16 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 149 · See all
  • K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007 · cites it directly142descendants
  • K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · cites it directly97descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 2 generations on94descendants
  • K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · 2 generations on83descendants
  • K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · 3 generations on52descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K813581Cruciate Ligament ButtonBiomet, Inc.1982—
+1K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007—
+1K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc.20041
+2K083070Toggleloc SystemBiomet Sports Medicine20086
+2K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.20113
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button…Arthrex, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200610
200710
200820
201010
201130
201220
2013100
201480
201550
201650
201770
201840
2019100
2020130
2021130
202260
2023160
2024140
2025130
2026130
FIG. 1 — Lineage of K813581, 1982–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (149)

See all 149

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

NumberDeviceApplicantDecidedDescendants
K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142
K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc.200497
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20086

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, K071704 (Biomet Sports Medicine, Inc., 2007) has gone furthest, with 142 descendants of its own.

How does its category compare?

All KGS devices

KGS Retention Device, Suture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGS

FDA has decided no KGS device since 2007.

Median 510(k) review, days · KGS

Too few KGS 510(k)s in any year since 2007 to give a median.

Recalls per year · KGS

No recall names KGS since 2007.

Adverse event reports per year · KGS

3in 2025

2007: 262008: 152009: 62010: 12011: 12012: 42013: 62014: 22015: 12016: 12017: 42019: 12020: 32021: 12023: 112024: 22025: 3
2007high 26 (2007) · low 0 (2018)2025

MAUDE reports naming product code KGS, 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
20070—026
20080—015
20090—06
20100—01
20110—01
20120—04
20130—06
20140—02
20150—01
20160—01
20170—04
20180—00
20190—01
20200—03
20210—01
20220—00
20230—011
20240—02
20250—03
20260—0—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in KGS

The KGS category page

  • K030031Soft Tissue Anchoring WashersAccu-Speed, Incorporated · 2003
  • K020480RBMSmith & Nephew, Inc. · 20021 recall
  • K964935Suture LockSmith & Nephew Endoscopy, Inc. · 1997
  • K941740Acufex Rotator Cuff Fixation ButtonAcufex Microsurgical, Inc. · 1995
  • K930675Mitek Cone WasherMitek Surgical Products, Inc. · 1993

https://510kreport.com/device/K813581 · printed Nov 5, 2026

Cite this page

510(k) Report. “K813581: Cruciate Ligament Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K813581

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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