510(k) · Cleared

Recalled · Class II · 2015

Anterolateral and Medial Locking Plating System

K072832510(k) TraditionalCleared Dec 14, 200772-day reviewClass II21 CFR 888.3030Recalls 2

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

DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Dec 14, 2007 as substantially equivalent to K990120 (Depuy Ace Medical Co., 1999) and 3 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1988. 58 later devices descend from it. It has been recalled 2 times.

Decided: Dec 14, 2007
Review: 72 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 4

Its longest line of descent runs back 1 generation to K882831 (1988). 4 ancestors in all. 58 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK882831 Ace Cancellous Bone ScrewBuckman Co., Inc. · 1988
This deviceK072832 Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007
Descendant · cites it directly · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Descendant · 2 generations on · 15 of its ownK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 2 generations on · 11 of its ownK193633 APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2010high 10 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 58 · See all

K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · cites it directly55descendants
K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016 · 2 generations on15descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882831	Ace Cancellous Bone Screw	Buckman Co., Inc.	1988	—
0 (this device)	K072832	Anterolateral and Medial Locking Plating System	DePuy Orthopaedics, Inc.	2007	—
+1	K092812	Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates	Synthes (Usa)	2010	—
+2	K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017	—
+2	K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	Gpc Medical, Ltd.	2016	—
+3	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+2	K193633	APTUS® Ankle Trauma System 2.8/3.5	Medartis AG	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1998	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2014	1	0
2015	1	0
2016	2	0
2017	4	0
2018	2	0
2019	2	0
2020	4	0
2021	3	0
2022	2	0
2023	10	0
2024	10	0
2025	7	0
2026	8	0

FIG. 1 — Lineage of K072832, 1988–2026Source: 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

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What was it cleared against? (4)

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
*	K990120	Modification of Depuy Ace Timax Medial Pilon Plate Summary page 1 …e fixation appliances Name: and accessories (21 CFR § 888.3030) Predicate Devices: DePuy K990120 TiMax Medial Pilon Plate DePuy K983853 TiMax Meta Plate…	Depuy Ace Medical Co.	1999	—
*	K983853	Depuy Ace Timax Meta Plate Summary page 1 …te Devices: DePuy K990120 TiMax Medial Pilon Plate DePuy K983853 TiMax Meta Plate De~~uy K905048 3.5mm Cortical Bone…	Depuy Ace Medical Co.	1998	—
*	K905048	Ace 3.5MM Cortical Bone Screw Summary page 1 …0 TiMax Medial Pilon Plate DePuy K983853 TiMax Meta Plate De~~uy K905048 3.5mm Cortical Bone De~uy K905048 Screws…	Ace Medical Co.	1991	—
*	K882831	Ace Cancellous Bone Screw Our reading of the summary gave K882381, FDA’s number for Pti Heart-Lift (TM) Cardiac Retraction Gloves-Steri (Pioneering Technologies, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Cancellous Bone Screws”.	Buckman Co., Inc.	1988	—

Also cleared against K990120: 2 other devices →

What descends from it? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K092812	Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates	Synthes (Usa)	2010	55
K111663	Trauma Internal Fixation Systems	DePuy Orthopaedics, Inc.	2012	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 20, 2015	Class II	Z-0450-2016	Process change control	These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the…
Dec 19, 2013	Class II	Z-0716-2014	Labeling mix-ups	3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K092812 (Synthes (Usa), 2010) has gone furthest, with 55 descendants of its own.
2 other devices also cite its predicate K990120.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 Medial Locking Plate is indicated for:

-Pilon Fractures: distal tibial intra-articular fractures

-High medial malleolar fractures

-Low boot type rotational distal extra-articular shaft fractures

while the Anterolateral Locking Plate is indicated for:

-Distal intra-articular tibia fractures

-Proximal tibia fractures

-Proximal and distal humerus fractures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072832 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072832: Anterolateral and Medial Locking Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072832

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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