510(k) Report

510(k) · Cleared

Cleared

Depuy Cannulated Bone Screw

K893512510(k) TraditionalCleared Aug 21, 1989108-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

Depuy, Inc. · HWC Screw, Fixation, Bone

Cleared on Aug 21, 1989 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 187 devices in its family, counting itself, has a Class I recall. 186 later devices descend from it.

Decided
Aug 21, 1989
Review
108 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

186 later devices descend from it, 4 citing it directly. 1 of the 187 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2012: 2 descendants cleared2003: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2011: 2 descendants cleared2008: 1 descendant cleared2025: 23 descendants cleared2010: 1 descendant cleared2016: 4 descendants cleared2015: 11 descendants cleared2017: 11 descendants cleared2013: 3 descendants cleared2021: 10 descendants cleared, 1 with a Class I recall12024: 27 descendants cleared2014: 2 descendants cleared2020: 10 descendants cleared2019: 10 descendants cleared2022: 15 descendants cleared2023: 21 descendants cleared2026: 30 descendants cleared1990200020102020
  1. This deviceK893512 Depuy Cannulated Bone ScrewDepuy, Inc. · 1989
  2. Descendant · cites it directly · 181 of its ownK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
  3. Descendant · 2 generations on · 180 of its ownK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
  4. Descendant · 3 generations on · 145 of its ownK100359 Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010
  5. Descendant · 4 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  6. Descendant · 5 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017

Showing 5 of 186 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12008: 12009: 12010: 12011: 22012: 22013: 32014: 22015: 112016: 42017: 112019: 102020: 102021: 102022: 152023: 212024: 272025: 232026: 30
2002high 30 (2026) · low 0 (2004)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 186 · See all
  • K021233Aap Cannulated ScrewsAap Implantate AG · 2002 · cites it directly181descendants
  • K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008 · 2 generations on180descendants
  • K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010 · 3 generations on145descendants
  • K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 4 generations on79descendants
  • K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 5 generations on74descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K893512Depuy Cannulated Bone ScrewDepuy, Inc.1989—
+1K021233Aap Cannulated ScrewsAap Implantate AG2002—
+2K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG2008—
+3K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc2010—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200810
200910
201010
201120
201220
201330
201420
2015110
201640
2017110
2019100
2020100
2021101
2022150
2023210
2024270
2025230
2026300
FIG. 1 — Lineage of K893512, 1989–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (186)

See all 186

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

NumberDeviceApplicantDecidedDescendants
K021233Aap Cannulated ScrewsAap Implantate AG2002181
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K092440Ascension Cannulated Screw SystemAscension Orthopedics, Inc.20090
K030619Odi 7.0MM Cannulated Screw SystemOrthopedic Designs, Inc.20030

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K021233 (Aap Implantate AG, 2002) has gone furthest, with 181 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—

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

  • P830055/S379ATTUNE Revision Knee SystemDepuy, Inc. · 2026
  • P830055/S377ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System…Depuy, Inc. · 2026
  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, Inc. · 2026

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/K893512 · printed Nov 4, 2026

Cite this page

510(k) Report. “K893512: Depuy Cannulated Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893512

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026