510(k) · Cleared

Cleared

Ace Cannulated Cortical Bone Screw

K903811510(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. 16 later devices descend from it.

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

16 later devices descend from it, 3 citing it directly.

This deviceK903811 Ace Cannulated Cortical Bone ScrewAce Medical Co. · 1990
Descendant · cites it directly · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
Descendant · cites it directly · 4 of its ownK083096 Latarjet Cortical Screw SetTag Medical Products · 2009 · Recalled
Descendant · 2 generations on · 3 of its ownK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
Descendant · 2 generations on · 2 of its ownK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
Descendant · 2 generations on · 2 of its ownK091694 Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J…Tag Medical Products · 2009 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2009high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 16 · See all

K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · cites it directly8descendants
K083096Latarjet Cortical Screw SetTag Medical Products · 2009 · cites it directly4descendants
K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · 2 generations on3descendants
K150889Suture Wires and Wire LoopsZimmer, Inc. · 2015 · 2 generations on2descendants
K091694Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)Tag Medical Products · 2009 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K903811	Ace Cannulated Cortical Bone Screw	Ace Medical Co.	1990	—
+1	K110895	Ortho Solutions Trauma Implants for Osteosynthesis	Ortho Solutions Limited	2011	—
+1	K083096	Latarjet Cortical Screw Set	Tag Medical Products	2009	5
+2	K163489	OrthoSolutions 'System26' Bone Screws	Ortho Solutions UK Limited	2017	1
+2	K150889	Suture Wires and Wire Loops	Zimmer, Inc.	2015	—
+2	K091694	Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)	Tag Medical Products	2009	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2011	2	0
2012	1	0
2015	2	0
2016	1	0
2017	1	0
2022	2	0
2023	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K903811, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K110895	Ortho Solutions Trauma Implants for Osteosynthesis	Ortho Solutions Limited	2011	8
K083096	Latarjet Cortical Screw Set	Tag Medical Products	2009	4
K111663	Trauma Internal Fixation Systems	DePuy Orthopaedics, Inc.	2012	1

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?

Of its descendants, K110895 (Ortho Solutions Limited, 2011) has gone furthest, with 8 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

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

https://510kreport.com/device/K903811 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903811: Ace Cannulated Cortical 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/K903811

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Record history

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