510(k) Report

510(k) · Cleared

Cleared

Resorbable NO Profile Screw and Washer

K012469510(k) TraditionalCleared Dec 3, 2001123-day reviewClass II21 CFR 888.3040

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

Biomet Manufacturing, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 3, 2001 as substantially equivalent to K982497 (Biomet, Inc., 1998) and 4 other predicates after a 123-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.

Decided
Dec 3, 2001
Review
123 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K911837 (1991). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1998: 3 other ancestors1995: 1 other ancestor2002: 1 descendant cleared2005: 1 descendant cleared2003: 1 descendant cleared2013: 1 descendant clearedK911837 · Suretac Polyglyconate Absorbable Fixation Device · Acufex Microsurgical, Inc. · 1991K984490 · Sutureless Anchor · Innovasive Devices, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K984490 · Sutureless Anchor · Innovasive Devices, Inc. · 1999K911837 · Suretac Polyglyconate Absorbable Fixation Device · Acufex Microsurgical, Inc. · 19910
  1. Root · 2 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
  2. 1 generation backK984490 Sutureless AnchorInnovasive Devices, Inc. · 1999
  3. This deviceK012469 Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc. · 2001
  4. Descendant · cites it directly · 3 of its ownK021832 Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc. · 2002
  5. Descendant · 2 generations on · 2 of its ownK033233 Lactosorb Tibial L-15 Screw and WasherBiomet, Inc. · 2003
  6. Descendant · 3 generations on · 0 of its ownK130731 Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
  7. Descendant · 2 generations on · 0 of its ownK051069 Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc. · 2005

Most influential descendants

Showing 4 of 4 · See all
  • K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc. · 2002 · cites it directly3descendants
  • K033233Lactosorb Tibial L-15 Screw and WasherBiomet, Inc. · 2003 · 2 generations on2descendants
  • K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013 · 3 generations on0descendants
  • K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K911837Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc.1991—
−1K984490Sutureless AnchorInnovasive Devices, Inc.1999—
0 (this device)K012469Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc.2001—
+1K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc.2002—
+2K033233Lactosorb Tibial L-15 Screw and WasherBiomet, Inc.2003—
+3K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC2013—
+2K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199830
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
201310
FIG. 1 — Lineage of K012469, 1991–2013Source: 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), 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? (5)

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
*K982497Arthrotek Interference Screw
Summary page 1
…t, Non-spinal, Non-metallic (888.3030) 87HWC and HTN Legally Marketed Devices To Which Substantial Equivalence is Claimed: Arthrotek Interference Screw (Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threade…
Biomet, Inc.19985
*K943806Harpoon Suture Anchors
Summary page 1
…and HTN Legally Marketed Devices To Which Substantial Equivalence is Claimed: Arthrotek Interference Screw (Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threader (Linvatec Corp., K993339) Indications for Us…
Biomet, Inc.1995—
*K973775Harpoon Suture Anchors
Summary page 1
…Legally Marketed Devices To Which Substantial Equivalence is Claimed: Arthrotek Interference Screw (Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threader (Linvatec Corp., K993339) Indications for Use: The R…
Biomet, Inc.1998—
*K984490Sutureless Anchor
Summary page 1
…uivalence is Claimed: Arthrotek Interference Screw (Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threader (Linvatec Corp., K993339) Indications for Use: The Resorbable No Profile Screw and Washer is indicate…
Innovasive Devices, Inc.1999—
*K993339Endopearl with Threader
Summary page 1
…Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threader (Linvatec Corp., K993339) Indications for Use: The Resorbable No Profile Screw and Washer is indicated for the following procedures: SO h LN ACL and P…
Linvatec Corp.1999—

Also cleared against K982497: 5 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc.20023

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 10 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K021832 (Biomet, Inc., 2002) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K982497.

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?

The Resorbable No Profile Screw and Washer is indicated for the following procedures:

ACL and PCL reconstruction

Medial collateral ligament repair

Lateral collateral ligament repair

Posterior oblique ligament repair

lliotibial band tenodesis reconstruction

Patellar ligament and tendon repair

This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

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 K982497

5 other devices cite the same predicate.

  • K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine · 20112 recalls
  • K041274Resorbable Interference ScrewArthrotek, Inc. · 20045 recalls
  • K021280Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd. · 2002
  • K014305Resorbable Lactosorb-L Acl CrosspinArthrotek, Inc. · 2002
  • K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030Bionx Implants, Ltd. · 1999

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 HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K012469 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012469: Resorbable NO Profile Screw and Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012469

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026