510(k) Report

510(k) · Cleared

Cleared

Ace Cannulated Self Tapping Cancellous Bone Screw

K903810510(k) TraditionalCleared Oct 16, 199057-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

Ace Medical Co. · HWC Screw, Fixation, Bone

Cleared on Oct 16, 1990 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 890 devices in its family, counting itself, has a Class I recall. 889 later devices descend from it.

Decided
Oct 16, 1990
Review
57 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

889 later devices descend from it, 12 citing it directly. 1 of the 890 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2014: 30 descendants cleared2012: 18 descendants cleared1999: 1 descendant cleared1996: 2 descendants cleared2011: 12 descendants cleared1998: 1 descendant cleared2019: 44 descendants cleared2006: 3 descendants cleared2005: 4 descendants cleared2008: 4 descendants cleared2010: 7 descendants cleared2009: 5 descendants cleared2017: 54 descendants cleared2026: 96 descendants cleared2025: 93 descendants cleared2007: 1 descendant cleared2022: 76 descendants cleared2021: 69 descendants cleared, 1 with a Class I recall12013: 18 descendants cleared2015: 39 descendants cleared2020: 57 descendants cleared2003: 1 descendant cleared1997: 1 descendant cleared2018: 34 descendants cleared2016: 28 descendants cleared2023: 95 descendants cleared2024: 96 descendants cleared1990200020102020
  1. This deviceK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
  2. Descendant · cites it directly · 836 of its ownK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
  3. Descendant · cites it directly · 531 of its ownK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. Descendant · 2 generations on · 245 of its ownK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
  6. Descendant · 3 generations on · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011

Showing 5 of 889 descendants. See all descendants

Descendants cleared per year

1996: 21997: 11998: 11999: 12003: 12005: 42006: 32007: 12008: 42009: 52010: 72011: 122012: 182013: 182014: 302015: 392016: 282017: 542018: 342019: 442020: 572021: 692022: 762023: 952024: 962025: 932026: 96
1996high 96 (2024) · low 0 (2000)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 889 · See all
  • K051296Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005 · cites it directly836descendants
  • K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · cites it directly531descendants
  • K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
  • K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010 · 2 generations on245descendants
  • K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 3 generations on241descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903810Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co.1990—
+1K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005—
+1K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc.20061
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
+2K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010—
+3K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199810
199910
200310
200540
200630
200710
200840
200950
201070
2011120
2012180
2013180
2014300
2015390
2016280
2017540
2018340
2019440
2020570
2021691
2022760
2023950
2024960
2025930
2026960
FIG. 1 — Lineage of K903810, 1990–2026Source: 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? (889)

See all 889

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

NumberDeviceApplicantDecidedDescendants
K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005836
K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc.2006531
K960533K3 Bone Screw SystemKinetikos Medical, Inc.199661
K960537K2 Bone Screw SystemKinetikos Medical, Inc.199641
K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH200528
K140891Biomet Cannulated Screw SystemBiomet, Inc.201416
K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH200512
K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190

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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K051296 (Depuy Spine, Inc., 2005) has gone furthest, with 836 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 Ace Medical Co.

21 FDA decisions under this applicant name. See the company

  • K972183Depuy Ace a.I.M. Titanium Tibial NailAce Medical Co. · 19972 recalls
  • K955472Ace Humerus & Radius PlatesAce Medical Co. · 1996
  • K955388Ace-Dupont Composite RingsAce Medical Co. · 1996
  • K9544856.5MM Solid Cancellous Bone ScrewAce Medical Co. · 1995
  • K954069Ace Cervical Traction Halozs, Tongs & PinsAce Medical Co. · 1995

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/K903810 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903810: Ace Cannulated Self Tapping Cancellous Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903810

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