510(k) · Cleared

Cleared

Depuy Ace Timax Pilon Plate

K982347510(k) TraditionalCleared Aug 31, 199856-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 Aug 31, 1998 after a 56-day review. The FDA summary names its predicate without a number. 262 later devices descend from it.

Decided: Aug 31, 1998
Review: 56 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK982347 Depuy Ace Timax Pilon PlateDepuy Ace Medical Co. · 1998
Descendant · cites it directly · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
Descendant · 2 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
Descendant · cites it directly · 98 of its ownK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
Descendant · 2 generations on · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
Descendant · 3 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011

Showing 5 of 262 descendants. See all descendants

Descendants cleared per year

2003high 31 (2023) · low 1 (2003)2026

Most influential descendants

Showing 5 of 262 · See all

K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · cites it directly161descendants
K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · 2 generations on143descendants
K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · cites it directly98descendants
K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · 2 generations on73descendants
K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 3 generations on69descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K982347	Depuy Ace Timax Pilon Plate	Depuy Ace Medical Co.	1998	—
+1	K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	1
+2	K062747	Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM	Arthrex, Inc.	2006	—
+1	K033639	Acumed Lower Extremity Congruent Plate System	Acumed, LLC	2004	10
+2	K073375	Newdeal Tibiaxys System	Newdeal Sas	2008	2
+3	K110670	VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…	Smith & Nephew, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	2	0
2006	3	0
2007	5	0
2008	2	0
2009	2	0
2010	2	0
2011	4	0
2012	4	0
2013	4	0
2014	14	0
2015	9	0
2016	7	0
2017	15	0
2018	6	0
2019	20	0
2020	20	0
2021	25	0
2022	13	0
2023	31	0
2024	25	0
2025	21	0
2026	26	0

FIG. 1 — Lineage of K982347, 1998–2026Source: 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? (1)

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
*	—	Synthes Stainless Steel Cloverleaf Plate Named without a submission number			—

What descends from it? (262)

See all 262

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

Number	Device	Applicant	Decided	Descendants
K031666	Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS	Arthrex, Inc.	2003	161
K033639	Acumed Lower Extremity Congruent Plate System	Acumed, LLC	2004	98
K052011	Pilonplate with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2005	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, K031666 (Arthrex, Inc., 2003) has gone furthest, with 161 descendants of its own.

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?

Pilon fractures - distal tibial intra-articular fractures

High medial malleolar fractures

Low Boot top type rotational distal extra-articular shaft fractures

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/K982347 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982347: Depuy Ace Timax Pilon Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982347

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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