510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Biomet Cannulated Screw System

K140891510(k) TraditionalCleared Jun 3, 201456-day reviewClass II21 CFR 888.3040Recalls 5

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 Jun 3, 2014 as substantially equivalent to K082874 (Biomet Trauma, 2009) and 7 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1992. 16 later devices descend from it. It has been recalled 5 times.

Decided
Jun 3, 2014
Review
56 days
Class
Class II
Product code
HWC
Recalls
5
Predicates
8

Its longest line of descent runs back 4 generations to K922322 (1992). 20 ancestors in all, the oldest K872859 (1987). 16 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2002: 2 other ancestors1996: 4 other ancestors1993: 1 other ancestor1990: 1 other ancestor1987: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1992: 1 other ancestor2022: 5 descendants cleared2020: 1 descendant cleared2021: 3 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2023: 2 descendants cleared2019: 1 descendant cleared2024: 2 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. · 2003K082874 · Biodrive Cannulated Screw System · Biomet Trauma · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 6 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K082874 · Biodrive Cannulated Screw System · Biomet Trauma · 2009K024086 · 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
  1. Root · 4 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
  2. 3 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
  3. 2 generations backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
  4. 1 generation backK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
  5. This deviceK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014
  6. Descendant · cites it directly · 8 of its ownK143188 3.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · Recalled
  7. Descendant · cites it directly · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
  8. Descendant · 2 generations on · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
  9. Descendant · cites it directly · 2 of its ownK213199 Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw…Stryker GmbH · 2022
  10. Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2014: 12018: 12019: 12020: 12021: 32022: 52023: 22024: 2
2014high 5 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 16 · See all
  • K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · cites it directly8descendants
  • K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · cites it directly3descendants
  • K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · 2 generations on3descendants
  • K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH · 2022 · cites it directly2descendants
  • K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922322Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc.1992—
−3K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc.2001—
−2K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003—
−1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009—
0 (this device)K140891Biomet Cannulated Screw SystemBiomet, Inc.2014—
+1K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp20141
+1K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw…Biomet, Inc.2020—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC2018—
+1K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH2022—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199210
199310
199640
200010
200110
200220
200410
200510
200710
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201810
201910
202010
202130
202250
202320
202420
FIG. 1 — Lineage of K140891, 1992–2024Source: 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? (8)

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
*K082874Biodrive Cannulated Screw System
Summary page 2
…V alloy is a commonly used material in orthopedic implants, and is a material that was used in predicate devices cleared in K082874, K903810, K(926047, and K(872859. Summary of The Biomet Cannulated Screw System is substantially equivalent to Subst…
Biomet Trauma2009—
*K926047Ace 8.0MM Cannulated Cancellous Bone Screw
Summary page 1
…to currently marketed BioDrive Cannulated Screw System (1(082874), DePuy/Ace 8.0mm Cannulated Cancellous Bone Screw (K(926047), DePuy/Ace Cannulated Self Tapping Cancellous Bone Screw (K(903810), Ace/DePuy…
Ace Orthopedic Manufacturing Co.1993—
*K903810Ace Cannulated Self Tapping Cancellous Bone Screw
Summary page 2
…s a commonly used material in orthopedic implants, and is a material that was used in predicate devices cleared in K082874, K903810, K(926047, and K(872859. Summary of The Biomet Cannulated Screw System is substantially equivalent to Substantial…
Ace Medical Co.1990—
*K872859Ace Cancellous Bone Screw
Summary page 1
…ew (K(926047), DePuy/Ace Cannulated Self Tapping Cancellous Bone Screw (K(903810), Ace/DePuy Ace Cancellous Bone Screw (K872859), Synthes Sterile 4.5mm Cannulated Screws (K(963172), Synthes Sterile 3.5mm and…
Ace Medical Co.1987—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…ellous Bone Screw (K(903810), Ace/DePuy Ace Cancellous Bone Screw (K872859), Synthes Sterile 4.5mm Cannulated Screws (K(963172), Synthes Sterile 3.5mm and 4.0mm Cannulated Screws (K(963192), Synthes 6.5mm C…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…rew (K872859), Synthes Sterile 4.5mm Cannulated Screws (K(963172), Synthes Sterile 3.5mm and 4.0mm Cannulated Screws (K(963192), Synthes 6.5mm Cannulated Screw (K(021932), Synthes 7.3mm Cannulated Slipped C…
Synthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…ated Screws (K(963172), Synthes Sterile 3.5mm and 4.0mm Cannulated Screws (K(963192), Synthes 6.5mm Cannulated Screw (K(021932), Synthes 7.3mm Cannulated Slipped Capital Femoral Epiphysis Screws (K(092909). Device Description:…
Synthes (Usa)20027
*K092909Synthes 7.3 MM Cannulated Slipped Capital Femoral Epiphysis Screws (Scfe)
Summary page 1
…63192), Synthes 6.5mm Cannulated Screw (K(021932), Synthes 7.3mm Cannulated Slipped Capital Femoral Epiphysis Screws (K(092909). Device Description: The Biomet Cannulated Screw System consists of bone screws, associated washe…
Synthes (Usa)2010—

Also cleared against K082874: 5 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp20148
K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203
K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222
K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221
K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220
K213301InCore Subtalar SystemNextremity Solutions, Inc.20210

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2020Class IIZ-0617-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020Class IIZ-0618-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
May 14, 2020Class IIZ-2304-2020Device DesignDistributed to the field without having completed design history files or design transfer activities
May 14, 2020Class IIZ-2303-2020Device DesignDistributed to the field without having completed design history files or design transfer activities
Dec 7, 2017Class IIZ-1064-2018Error in labelingOne lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
  • 3 of the 20 ancestors have a recall of any class.
  • Of its descendants, K143188 (Biomet Manufacturing Corp, 2014) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K082874.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in: 1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow. 2. Arthrodesis of the foot, wrist and elbow. 3. Small and long bone osteotomies. 4. Fracture fixation of small bones, small bone fragments and long bones. Large Cannulated Screws (5mm and larger in diameter) are intended for use in: 1. Fixation of fractures in long bones and long bone…

Read the full statement (152 words)

Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:

1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.

2. Arthrodesis of the foot, wrist and elbow.

3. Small and long bone osteotomies.

4. Fracture fixation of small bones, small bone fragments and long bones.

Large Cannulated Screws (5mm and larger in diameter) are intended for use in:

1. Fixation of fractures in long bones and long bone fragments.

2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).

3. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.

Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:

1. Slipped capital femoral epiphysis

2. Pediatric femoral neck fractures

3. Tibial plateau fractures

4. SI joint disruptions

5. Intercondylar femur fractures

6. Subtalar arthrodesis

7. Fixation of pelvis and iliosacral joint.

Indications for use as stated in the FDA summary.

Also cleared against K082874

5 other devices cite the same predicate.

  • K200291CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020
  • K170594I.B.S. osteosynthesis screwsIn2bones Sas · 2017
  • K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 20141 recall
  • K140018TSP Hip Fracture Plating SystemBiomet, Inc. · 20142 recalls
  • K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 20101 recall

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

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/K140891 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140891: Biomet Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140891

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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