510(k) · Cleared

Cleared

Depuy Ace Spider Plate

K990392510(k) TraditionalCleared Mar 23, 199942-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Ace Medical Co. · HRS Plate, Fixation, Bone

Cleared on Mar 23, 1999 as substantially equivalent to K965028 (Acu Med, Inc., 1997) after a 42-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.

Decided: Mar 23, 1999
Review: 42 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K965028 (1997). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK965028 Acumed Suture WasherAcu Med, Inc. · 1997
This deviceK990392 Depuy Ace Spider PlateDepuy Ace Medical Co. · 1999
Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
Descendant · 2 generations on · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025

Most influential descendants

Showing 2 of 2 · See all

K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K965028	Acumed Suture Washer	Acu Med, Inc.	1997	—
0 (this device)	K990392	Depuy Ace Spider Plate	Depuy Ace Medical Co.	1999	—
+1	K111663	Trauma Internal Fixation Systems	DePuy Orthopaedics, Inc.	2012	17
+2	K243761	A.L.P.S. Small Fragment Plating System	Biomet Orthopedics	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2025	1	0

FIG. 1 — Lineage of K990392, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K965028	Acumed Suture Washer Summary page 1 …w hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone. The Acumed Suture Washer (K965028) is intended for soft tissue fixation, small and large bone fixation and is used in conjunction with a titanium bone screw. The D…	Acu Med, Inc.	1997	—
*	—	DePuy ACE Orthopaedic Washer Named without a submission number			—

Also cleared against K965028: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
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?

Its one ancestor has no recall.
Of its descendants, K111663 (DePuy Orthopaedics, Inc., 2012) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K965028.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

Fixation of Metaphyseal Fractures of the Distal Tibia

Proximal Metaphyseal Tibial Fractures

Calcaneus Body Fractures

Proximal Humeral Head/Shaft Fractures

Distal Femur Fracture — Comminuted Shaft Fractures

Fixation of soft tissue, such as tendon and ligaments, to bone

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

https://510kreport.com/device/K990392 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990392: Depuy Ace Spider Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990392

Report an extraction error

Are you the manufacturer?

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