510(k) Report

510(k) · Cleared

Cleared

Self-Countersinking Bone Screw

K013534510(k) TraditionalCleared Dec 17, 200155-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 Orthopedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 17, 2001 as substantially equivalent to K962823 (Synthes (Usa), 1996) and 3 other predicates after a 55-day review. Its family tree reaches back 1 generation to 1992. 241 later devices descend from it.

Decided
Dec 17, 2001
Review
55 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K922322 (1992). 4 ancestors in all. 241 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1992: 1 other ancestor2003: 1 descendant cleared2009: 3 descendants cleared2002: 1 descendant cleared2015: 9 descendants cleared2013: 4 descendants cleared2016: 6 descendants cleared2012: 2 descendants cleared2021: 19 descendants cleared2014: 5 descendants cleared2017: 15 descendants cleared2020: 13 descendants cleared2010: 1 descendant cleared2024: 31 descendants cleared2022: 28 descendants cleared2026: 31 descendants cleared2018: 3 descendants cleared2019: 5 descendants cleared2025: 31 descendants cleared2023: 33 descendants clearedK922322 · Alphatec 3.5MM Znnulated Cortical Lag Screw · Alphatec Mfg., Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 25 descendants4 generations forward: 30 descendants5 generations forward: 22 descendants6 generations forward: 26 descendants7 generations forward: 28 descendants8 generations forward: 29 descendants9 generations forward: 14 descendants10 generations forward: 12 descendants11 generations forward: 18 descendants12 generations forward: 17 descendants13 generations forward: 9 descendants14 generations forward: 1 descendant K922322 · Alphatec 3.5MM Znnulated Cortical Lag Screw · Alphatec Mfg., Inc. · 19920+5+10
  1. Root · 1 generation backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
  2. This deviceK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
  3. Descendant · cites it directly · 171 of its ownK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
  4. Descendant · 2 generations on · 168 of its ownK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
  5. Descendant · 3 generations on · 143 of its ownK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · Recalled
  6. Descendant · 4 generations on · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled
  7. Descendant · 5 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013

Showing 5 of 241 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12009: 32010: 12012: 22013: 42014: 52015: 92016: 62017: 152018: 32019: 52020: 132021: 192022: 282023: 332024: 312025: 312026: 31
2002high 33 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 241 · See all
  • K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003 · cites it directly171descendants
  • K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009 · 2 generations on168descendants
  • K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · 3 generations on143descendants
  • K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · 4 generations on142descendants
  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 5 generations on108descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922322Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc.1992—
0 (this device)K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc.2001—
+1K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003—
+2K082874Biodrive Cannulated Screw SystemBiomet Trauma2009—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200930
201010
201220
201340
201450
201590
201660
2017150
201830
201950
2020130
2021190
2022280
2023330
2024310
2025310
2026310
FIG. 1 — Lineage of K013534, 1992–2026Source: 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), 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? (6)

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
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…Self-Countersinking Bone Screw bone screw Screw, Fixation, Bone (888.3040) 87HWC Substantially Equivalent Devices: Synthes 3.0mm Cannulated Screw and Threaded Washer, K962823, Synthes (USA), Synthes 3.5mm and 4.0mm Cannulated Screws, K963192, Synthes (USA), DePuy-Ace 4.0mm Cannulated Cancellous Screw, 5…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…888.3040) 87HWC Substantially Equivalent Devices: Synthes 3.0mm Cannulated Screw and Threaded Washer, K962823, Synthes (USA), Synthes 3.5mm and 4.0mm Cannulated Screws, K963192, Synthes (USA), DePuy-Ace 4.0mm Cannulated Cancellous Screw, 510(k) unknown, Alphatec 2.7mm (K923256), 3.5mm (K922332), and 4.0mm…
Synthes (Usa)1996—
*K923256Alphatec 2.7 MM Cannulated Cortical Lag Screw
Summary page 1
…, K962823, Synthes (USA), Synthes 3.5mm and 4.0mm Cannulated Screws, K963192, Synthes (USA), DePuy-Ace 4.0mm Cannulated Cancellous Screw, 510(k) unknown, Alphatec 2.7mm (K923256), 3.5mm (K922332), and 4.0mm (510(k) unknown) Cortical Lag Screw, Alphatec Mfg, Inc. Indications for Use: The Self-Countersinkin…
Alphatec Mfg., Inc.1992—
*K922322Alphatec 3.5MM Znnulated Cortical Lag Screw
Our OCR of the scanned summary read K922332, FDA’s number for Bartels Epstein-Barr Virus Igg Eia (Baxter Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Alphatec 3.5mm Cortical Lag Screw”.
Alphatec Mfg., Inc.1992—
*—DePuy-Ace 4.0mm Cannulated Cancellous Screw
Named without a submission number
—
*—Alphatec 4.0mm Cortical Lag Screw
Named without a submission number
—

Also cleared against K962823: 19 other devices →

What descends from it? (241)

See all 241

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

NumberDeviceApplicantDecidedDescendants
K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003171
K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968
K022952Modular Head Bone ScrewBiomet, Inc.20020

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K024086 (Biomet Orthopedics, Inc., 2003) has gone furthest, with 171 descendants of its own.
  • 19 other devices also cite its predicate K962823.

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 Self-Countersinking Bone Screw is indicated for the following conditions:

Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna as well as fractures in the patella

Fixation of small bones such as those in the foot, ankle, wrist, and elbow

Ligament reconstruction

Arthrodesis of the foot, ankle, wrist, and elbow

Small bone osteotomies

Osteochondritis dissecans

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 K962823

19 other devices cite the same predicate.

  • K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
  • K170021SMV Scientific Cannulated ScrewsSmv Scientific · 2017
  • K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
  • K142776Flow-ScrewFlow-Fx, LLC · 2015
  • K142057Infix Cannulated Screw SystemInfix Medical, LLC · 2015
  • K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 20141 recall

More from Biomet Orthopedics, Inc.

35 FDA decisions under this applicant name. See the company

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 20082 recalls
  • K070955Acid Etched Lag ScrewsBiomet Orthopedics, Inc. · 2007
  • K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K013534 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013534: Self-Countersinking Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013534

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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