510(k) · Cleared

Cleared

Ace 3.5MM Cortical Bone Screw

K905048510(k) TraditionalCleared Jan 30, 199183-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 Jan 30, 1991 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it.

Decided: Jan 30, 1991
Review: 83 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK905048 Ace 3.5MM Cortical Bone ScrewAce Medical Co. · 1991
Descendant · cites it directly · 58 of its ownK072832 Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
Descendant · 2 generations on · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
Descendant · cites it directly · 37 of its ownK072083 Small Fragment Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
Descendant · 2 generations on · 32 of its ownK101421 Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon…DePuy Orthopaedics, Inc. · 2010
Descendant · 3 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2007high 13 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 81 · See all

K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly58descendants
K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · 2 generations on55descendants
K072083Small Fragment Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly37descendants
K101421Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…DePuy Orthopaedics, Inc. · 2010 · 2 generations on32descendants
K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K905048	Ace 3.5MM Cortical Bone Screw	Ace Medical Co.	1991	—
+1	K072832	Anterolateral and Medial Locking Plating System	DePuy Orthopaedics, Inc.	2007	2
+2	K092812	Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates	Synthes (Usa)	2010	—
+1	K072083	Small Fragment Locking Plating System	DePuy Orthopaedics, Inc.	2007	2
+2	K101421	Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates…	DePuy Orthopaedics, Inc.	2010	—
+3	K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2010	2	0
2011	1	0
2012	2	0
2014	4	0
2015	4	0
2016	3	0
2017	6	0
2018	2	0
2019	3	0
2020	4	0
2021	3	0
2022	2	0
2023	10	0
2024	13	0
2025	10	0
2026	10	0

FIG. 1 — Lineage of K905048, 1991–2026Source: 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? (81)

See all 81

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

Number	Device	Applicant	Decided	Descendants
K072832	Anterolateral and Medial Locking Plating System	DePuy Orthopaedics, Inc.	2007	58
K072083	Small Fragment Locking Plating System	DePuy Orthopaedics, Inc.	2007	37
K150126	Life Spine Cannulated Screws	Life Spine, Inc.	2015	3

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, K072832 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 58 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/K905048 · printed Nov 5, 2026

Cite this page

510(k) Report. “K905048: Ace 3.5MM Cortical Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K905048

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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