510(k) Report

510(k) · Cleared

Recalled · 2009

Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped

K984209510(k) TraditionalCleared Feb 3, 199971-day reviewClass II21 CFR 888.3040Recalls 4

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 Feb 3, 1999 after a 71-day review. The FDA summary names no predicate by number. 14 later devices descend from it. It has been recalled 4 times.

Decided
Feb 3, 1999
Review
71 days
Class
Class II
Product code
HWC
Recalls
4
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2008: 1 descendant cleared2011: 3 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2019: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared1995200020052010201520202025
  1. This deviceK984209 Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel…Biomet, Inc. · 1999
  2. Descendant · cites it directly · 11 of its ownK082949 Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008
  3. Descendant · 2 generations on · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12011: 32014: 12016: 12017: 12019: 12020: 22025: 22026: 1
2006high 3 (2011) · low 0 (2007)2026

Most influential descendants

Showing 5 of 14 · See all
  • K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008 · cites it directly11descendants
  • K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · 2 generations on7descendants
  • K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 3 generations on2descendants
  • K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · 2 generations on2descendants
  • K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K984209Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel…Biomet, Inc.1999—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.2008—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.20111
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.20191
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.20113
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201130
201410
201610
201710
201910
202020
202520
202610
FIG. 1 — Lineage of K984209, 1999–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811
K063244Arc Surgical Bone Reduction ScrewArc Surgical, LLC20061

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 2, 2009Not classifiedZ-2285-2009Nonconforming Material/ComponentSome devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009Not classifiedZ-2287-2009Nonconforming Material/ComponentSome devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009Not classifiedZ-2286-2009Nonconforming Material/ComponentSome devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009Not classifiedZ-2284-2009Nonconforming Material/ComponentSome devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K082949 (OrthoPediatrics Corp., 2008) has gone furthest, with 11 descendants of its own.

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 cannulated screws maybe used for fixation of long bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedures where other treatments or devices have failed, arthrodesis, and in conjunction with other fixation hardware.) These cannulated screws are not to be used for spinal application or Carpal Tunnel Syndrome.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K984209 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984209: Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984209

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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