510(k) · Cleared

Cleared

Depuy Ace Timax Calcaneal Peri-Articular Plate

K981775510(k) TraditionalCleared Jul 29, 199870-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 Jul 29, 1998 as substantially equivalent to K915818 (Synthes (Usa), 1992) after a 70-day review. Its family tree reaches back 1 generation to 1992. 112 later devices descend from it.

Decided: Jul 29, 1998
Review: 70 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915818 (1992). 112 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
This deviceK981775 Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998
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
Descendant · 3 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
Descendant · 3 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2004high 15 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 112 · See all

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
K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 3 generations on56descendants
K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 3 generations on53descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915818	Synthes (R) Titanium Small Reconstruction Plate	Synthes (Usa)	1992	2
0 (this device)	K981775	Depuy Ace Timax Calcaneal Peri-Articular Plate	Depuy Ace Medical Co.	1998	—
+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	—
+3	K100176	Ascension Ankle Fusion Plate System	Ascension Orthopedics, Inc.	2010	—
+3	K121425	Ortholoc 3DI Ankle Fusion Plating System	Wrightmedicaltechnologyinc	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2006	2	0
2007	4	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2012	3	0
2013	2	0
2014	4	0
2015	1	0
2016	1	0
2017	9	0
2018	4	0
2019	6	0
2020	8	0
2021	11	0
2022	5	0
2023	15	0
2024	10	0
2025	9	0
2026	12	0

FIG. 1 — Lineage of K981775, 1992–2026Source: 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
*	K915818	Synthes (R) Titanium Small Reconstruction Plate Summary page 1 …1-4V ELI (per ASTM standard F136). The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is similar in design and function to the Synthes Calcaneal Plate (510(k) approval K915818). 00/ % WEALTY ot e, <, ) e Ya1a SERVICES - Y, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servic…	Synthes (Usa)	1992	2

Also cleared against K915818: 3 other devices →

What descends from it? (112)

See all 112

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

Number	Device	Applicant	Decided	Descendants
K033639	Acumed Lower Extremity Congruent Plate System	Acumed, LLC	2004	98
K041786	Calcamea Plate	New Deal, S.A.	2004	13
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 a recall.
Of its descendants, K033639 (Acumed, LLC, 2004) has gone furthest, with 98 descendants of its own.
3 other devices also cite its predicate K915818.

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?

The DePuy ACE TIMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:

Intra-articular fractures of the calcaneus

Extra-articular fractures of the calcaneus

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/K981775 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981775: Depuy Ace Timax Calcaneal Peri-Articular Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981775

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