510(k) Report

510(k) · Cleared

Recalled · 2009

Micromax Suture Anchor

K040475510(k) TraditionalCleared May 21, 200487-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, Inc. · HWC Screw, Fixation, Bone

Cleared on May 21, 2004 as substantially equivalent to K012572 (Biomet, Inc., 2001) after an 87-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it. It has been recalled once.

Decided
May 21, 2004
Review
87 days
Class
Class II
Product code
HWC
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K931519 (1994). 5 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor2008: 1 descendant cleared2011: 1 descendant cleared2020: 2 descendants cleared2013: 3 descendants clearedK931519 · Acufex Suretac · Acufex Microsurgical, Inc. · 1994K012572 · Soft Tissue Screw and Washer · Biomet, Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 2 descendants K012572 · Soft Tissue Screw and Washer · Biomet, Inc. · 2001K931519 · Acufex Suretac · Acufex Microsurgical, Inc. · 19940
  1. Root · 2 generations backK931519 Acufex SuretacAcufex Microsurgical, Inc. · 1994
  2. 1 generation backK012572 Soft Tissue Screw and WasherBiomet, Inc. · 2001
  3. This deviceK040475 Micromax Suture AnchorBiomet, Inc. · 2004
  4. Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
  6. Descendant · 2 generations on · 0 of its ownK193402 ALLthread PEEK Suture AnchorBiomet, Inc. · 2020
  7. Descendant · 2 generations on · 0 of its ownK192942 ALLthread Titanium Suture AnchorBiomet, Inc. · 2020
  8. Descendant · 2 generations on · 0 of its ownK123485 Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors…Biomet Sports Medicine · 2013 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12013: 32020: 2
2008high 3 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
  • K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · 2 generations on2descendants
  • K193402ALLthread PEEK Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
  • K192942ALLthread Titanium Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
  • K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K931519Acufex SuretacAcufex Microsurgical, Inc.1994—
−1K012572Soft Tissue Screw and WasherBiomet, Inc.2001—
0 (this device)K040475Micromax Suture AnchorBiomet, Inc.2004—
+1K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20088
+2K110473Nanotack Suture Anchor 1.4MMPivot Medical2011—
+2K193402ALLthread PEEK Suture AnchorBiomet, Inc.2020—
+2K192942ALLthread Titanium Suture AnchorBiomet, Inc.2020—
+2K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless…Biomet Sports Medicine20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201330
202020
FIG. 1 — Lineage of K040475, 1994–2020Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (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
*K012572Soft Tissue Screw and Washer
Summary page 1
…the cellular Krebs cycle. The material and manufacturing for this device is identical to the predicate device, LactoSorb® L15 Soft Tissue Screw and Washer, K012572. The suture anchor measures 3.0mm in diameter and 9.0mm in length. It is a two-piece assembly, consisting of a b…
Biomet, Inc.2001—

Also cleared against K012572: 6 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20086

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 11, 2009Not classifiedZ-0611-2010Labeling mix-upsThe anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K080088 (Biomet Manufacturing, Inc., 2008) has gone furthest, with 6 descendants of its own.
  • 6 other devices also cite its predicate K012572.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

Indications for the MicroMax™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee. Specific indications are as follows: Shoulder Indications. · Bankart repair · SLAP lesion repair · Acromioclavicular (ACL) separation · Rotator cuff repair · Capsule repair or capsuloabral reconstruction · Biceps tenodesis • Deltoid repair Wrist Indications: · Scapholunate ligament reconstruction Tennis elbow repair Ulnar…

Read the full statement (128 words)

Indications for the MicroMax™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee. Specific indications are as follows:

Shoulder Indications.

· Bankart repair

· SLAP lesion repair

· Acromioclavicular (ACL) separation

· Rotator cuff repair

· Capsule repair or capsuloabral reconstruction

· Biceps tenodesis

• Deltoid repair

Wrist Indications:

· Scapholunate ligament reconstruction

Tennis elbow repair

Ulnar or radial collateral ligament reconstruction

Biceps tendon reattachment

*Medial and lateral repairs

Knee Indications (Extra-capsularrepair).

* Medial collateral ligament repair

* Lateral collateral -ligament repair

* Posterior oblique ligament repair

* Joint capsule closure

· Iliotibial band tenodesis reconstruction

* Patellar ligament/tendon repair

· Vastus medialis obliquus (VMO) muscle advancement

The device is pre-loaded with suture for use at the discretion of the physician.

Indications for use as stated in the FDA summary.

Also cleared against K012572

6 other devices cite the same predicate.

  • K081172Composite Hitch Suture AnchorBiomet Manufacturing Corp · 2008
  • K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd. · 2008
  • K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 20071 recall
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K041274Resorbable Interference ScrewArthrotek, Inc. · 20045 recalls
  • K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T…Linvatec Biomaterials, Inc. · 2004

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

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The HWC category page

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https://510kreport.com/device/K040475 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040475: Micromax Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040475

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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