510(k) Report

510(k) · Cleared

Recalled · 2008

Titanium Toggle Button (S)

K033838510(k) TraditionalCleared Feb 13, 200465-day reviewClass II21 CFR 888.3040Recalls 1

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

Biomet Manufacturing, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Feb 13, 2004 as substantially equivalent to K813581 (Biomet, Inc., 1982) and 2 other predicates after a 65-day review. Its family tree reaches back 3 generations to 1992. 97 later devices descend from it. It has been recalled once.

Decided
Feb 13, 2004
Review
65 days
Class
Class II
Product code
MBI
Recalls
1
Predicates
3

Its longest line of descent runs back 3 generations to K922559 (1992). 6 ancestors in all, the oldest K813581 (1982). 97 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1982: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor2008: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2019: 7 descendants cleared2013: 2 descendants cleared2015: 4 descendants cleared2016: 3 descendants cleared2017: 3 descendants cleared2014: 7 descendants cleared2012: 1 descendant cleared2020: 7 descendants cleared2021: 9 descendants cleared2025: 10 descendants cleared2023: 11 descendants cleared2024: 13 descendants cleared2018: 2 descendants cleared2022: 5 descendants cleared2026: 10 descendants clearedK922559 · Acufex Endofix Button · Acufex Microsurgical, Inc. · 1992K980155 · Endobutton Continuous Loop · Smith & Nephew, Inc. · 1998K984550 · Pre-Threaded Endobutton · Smith & Nephew, Inc. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 11 descendants3 generations forward: 24 descendants4 generations forward: 19 descendants5 generations forward: 17 descendants6 generations forward: 10 descendants7 generations forward: 11 descendants8 generations forward: 2 descendants K984550 · Pre-Threaded Endobutton · Smith & Nephew, Inc. · 1999K980155 · Endobutton Continuous Loop · Smith & Nephew, Inc. · 1998K922559 · Acufex Endofix Button · Acufex Microsurgical, Inc. · 19920+5
  1. Root · 3 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
  2. 2 generations backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
  3. 1 generation backK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
  4. This deviceK033838 Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004
  5. Descendant · cites it directly · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
  6. Descendant · 2 generations on · 52 of its ownK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
  7. Descendant · 3 generations on · 40 of its ownK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
  8. Descendant · 2 generations on · 35 of its ownK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
  9. Descendant · 4 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12008: 12012: 12013: 22014: 72015: 42016: 32017: 32018: 22019: 72020: 72021: 92022: 52023: 112024: 132025: 102026: 10
2004high 13 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 97 · See all
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · cites it directly94descendants
  • K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · 2 generations on52descendants
  • K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015 · 3 generations on40descendants
  • K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp · 2013 · 2 generations on35descendants
  • K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 4 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922559Acufex Endofix ButtonAcufex Microsurgical, Inc.1992—
−2K980155Endobutton Continuous LoopSmith & Nephew, Inc.1998—
−1K984550Pre-Threaded EndobuttonSmith & Nephew, Inc.1999—
0 (this device)K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc.2004—
+1K083070Toggleloc SystemBiomet Sports Medicine20086
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button…Arthrex, Inc.2012—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp2015—
+2K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc…Biomet Manufacturing Corp20133
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200810
201210
201320
201470
201540
201630
201730
201820
201970
202070
202190
202250
2023110
2024130
2025100
2026100
FIG. 1 — Lineage of K033838, 1992–2026Source: 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), 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 MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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
*K813581Cruciate Ligament Button
Summary page 1
…Fastener, fixation, nondegradable, soft tissue (888.3040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Cruciate Ligament Button (K813581): Biomet, Inc. * Pre-Threaded EndoButton (K984550): Smith and Nephew, Inc. * Endobutton Continuous Loop…
Biomet, Inc.1982—
*K984550Pre-Threaded Endobutton
Summary page 1
…ally Marketed Devices To Which Substantial Equivalence Is Claimed: * Cruciate Ligament Button (K813581): Biomet, Inc. * Pre-Threaded EndoButton (K984550): Smith and Nephew, Inc. * Endobutton Continuous Loop (K980155):. Smith and Nephew, Inc. Device Description: The T…
Smith & Nephew, Inc.1999—
*K980155Endobutton Continuous Loop
Summary page 1
…* Cruciate Ligament Button (K813581): Biomet, Inc. * Pre-Threaded EndoButton (K984550): Smith and Nephew, Inc. * Endobutton Continuous Loop (K980155):. Smith and Nephew, Inc. Device Description: The Titanium Toggle Buttons are a toggle bar designed with one or two eyelets thr…
Smith & Nephew, Inc.1998—

Also cleared against K813581: 2 other devices →

What descends from it? (97)

See all 97

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

NumberDeviceApplicantDecidedDescendants
K083070Toggleloc SystemBiomet Sports Medicine200894
K041261Femoral HookArthrotek, Inc.20041
K053461Ezloc Femoral Fixation DeviceArthrotek, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 24, 2008Not classifiedZ-0582-2012Employee errorSix sizes of ToggleLoc, Artificial Ligament Fixation Device, have been manufactured with the suture pull hole drilled in the wrong location on the device. The ToggleLoc implant is deployed with a suture that pulls the device through the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K083070 (Biomet Sports Medicine, 2008) has gone furthest, with 94 descendants of its own.
  • 2 other devices also cite its predicate K813581.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Indications for use as stated in the FDA summary.

Also cleared against K813581

2 other devices cite the same predicate.

  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls
  • K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K033838 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033838: Titanium Toggle Button (S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033838

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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