510(k) Report

510(k) · Cleared

Cleared

Biodrive Cannulated Screw System

K082874510(k) TraditionalCleared Feb 5, 2009129-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 Trauma · HWC Screw, Fixation, Bone

Cleared on Feb 5, 2009 as substantially equivalent to K024086 (Biomet Orthopedics, Inc., 2003) and 8 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1992. 168 later devices descend from it.

Decided
Feb 5, 2009
Review
129 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
9

Its longest line of descent runs back 3 generations to K922322 (1992). 16 ancestors in all, the oldest K903810 (1990). 168 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2002: 2 other ancestors2001: 1 other ancestor1996: 4 other ancestors2000: 1 other ancestor1990: 1 other ancestor1992: 1 other ancestor2014: 3 descendants cleared2017: 6 descendants cleared2020: 9 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared2018: 3 descendants cleared2022: 25 descendants cleared2021: 14 descendants cleared2026: 23 descendants cleared2023: 24 descendants cleared2015: 2 descendants cleared2016: 3 descendants cleared2013: 2 descendants cleared2019: 3 descendants cleared2024: 23 descendants cleared2025: 26 descendants clearedK922322 · Alphatec 3.5MM Znnulated Cortical Lag Screw · Alphatec Mfg., Inc. · 1992K013534 · Self-Countersinking Bone Screw · Biomet Orthopedics, Inc. · 2001K024086 · Propeller Head Small Cannulated Screw System · Biomet Orthopedics, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 9 descendants4 generations forward: 18 descendants5 generations forward: 26 descendants6 generations forward: 28 descendants7 generations forward: 13 descendants8 generations forward: 12 descendants9 generations forward: 18 descendants10 generations forward: 17 descendants11 generations forward: 9 descendants12 generations forward: 1 descendant K024086 · Propeller Head Small Cannulated Screw System · Biomet Orthopedics, Inc. · 2003K013534 · Self-Countersinking Bone Screw · Biomet Orthopedics, Inc. · 2001K922322 · Alphatec 3.5MM Znnulated Cortical Lag Screw · Alphatec Mfg., Inc. · 19920+5+10
  1. Root · 3 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
  2. 2 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
  3. 1 generation backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
  4. This deviceK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
  5. Descendant · cites it directly · 143 of its ownK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · Recalled
  6. Descendant · 2 generations on · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled
  7. Descendant · 3 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  8. Descendant · 4 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  9. Descendant · 5 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020

Showing 5 of 168 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 22014: 32015: 22016: 32017: 62018: 32019: 32020: 92021: 142022: 252023: 242024: 232025: 262026: 23
2010high 26 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 168 · See all
  • K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · cites it directly143descendants
  • K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · 2 generations on142descendants
  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 3 generations on108descendants
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 4 generations on93descendants
  • K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 5 generations on72descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922322Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc.1992—
−2K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc.2001—
−1K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003—
0 (this device)K082874Biodrive Cannulated Screw SystemBiomet Trauma2009—
+1K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199640
200010
200110
200220
200410
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201320
201430
201520
201630
201760
201830
201930
202090
2021140
2022250
2023240
2024230
2025260
2026230
FIG. 1 — Lineage of K082874, 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 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? (9)

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
*K024086Propeller Head Small Cannulated Screw System
Summary page 1
…Fixation, Bone (888.3040) Device Classification: [I Predicate Device: Propeller Head Small Cannulated Screw System (K024086) Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945,…
Biomet Orthopedics, Inc.2003—
*K070955Acid Etched Lag Screws
Summary page 1
…redicate Device: Propeller Head Small Cannulated Screw System (K024086) Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K96…
Biomet Orthopedics, Inc.2007—
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 1
…System (K024086) Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823) DePuy SIJF Cannulated…
Synthes (Usa)20011
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…(K024086) Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823) DePuy SIJF Cannulated Screw Sy…
Synthes (Usa)20027
*K040765Synthes 5.0/7.3 MM Cannulated Locking Screws
Summary page 1
…Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823) DePuy SIJF Cannulated Screw System (KO51296) Non-Clinical Testing:…
Synthes (Usa)2004—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823) DePuy SIJF Cannulated Screw System (KO51296) Non-Clinical Testing: An…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823) DePuy SIJF Cannulated Screw System (KO51296) Non-Clinical Testing: An engineeri…
Synthes (Usa)1996—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…Acid Etched Lag Screws (K070955) Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823) DePuy SIJF Cannulated Screw System (KO51296) Non-Clinical Testing: An engineering ration…
Synthes (Usa)1996—
*K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005—

Also cleared against K024086: 1 other device →

What descends from it? (168)

See all 168

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

NumberDeviceApplicantDecidedDescendants
K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine2010143
K140891Biomet Cannulated Screw SystemBiomet, Inc.201416
K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp20148
K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202
K170594I.B.S. osteosynthesis screwsIn2bones Sas20171
K140018TSP Hip Fracture Plating SystemBiomet, Inc.20141

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 17 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
  • 3 of the 16 ancestors have a recall of any class.
  • Of its descendants, K093629 (Biomet Spine, 2010) has gone furthest, with 143 descendants of its own.
  • 1 other device also cites its predicate K024086.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 BioDrive® Cannulated Screw System is indicated for the following:

Fixation of fractures in long bones

Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow

Arthrodesis of the foot, wrist and elbow

Small and long bone osteotomies

Fixation of pelvis and the illiosacral joint

Indications for use as stated in the FDA summary.

Also cleared against K024086

1 other device cites the same predicate.

  • K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC · 2009

More from Biomet Trauma

7 FDA decisions under this applicant name. See the company

  • K091976Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailBiomet Trauma · 20092 recalls
  • K092078Optilock Periarticular PlatingBiomet Trauma · 2009
  • K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 20081 recall
  • K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008
  • K071325Biomet Variable Locking Plate SystemBiomet Trauma · 2007

Recent decisions in HWC

The HWC category page

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  • 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/K082874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082874: Biodrive Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082874

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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