510(k) · Cleared

Cleared

Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate,

K091294510(k) TraditionalCleared Jul 24, 200981-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 Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 24, 2009 after an 81-day review. The FDA summary names no predicate by number. 155 later devices descend from it.

Decided: Jul 24, 2009
Review: 81 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK091294 Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate…DePuy Orthopaedics, Inc. · 2009
Descendant · cites it directly · 154 of its ownK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
Descendant · 2 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
Descendant · 3 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
Descendant · 2 generations on · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled

Showing 5 of 155 descendants. See all descendants

Descendants cleared per year

2010high 20 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 155 · See all

K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…DePuy Orthopaedics, Inc. · 2010 · cites it directly154descendants
K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 2 generations on97descendants
K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 3 generations on95descendants
K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on46descendants
K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K091294	Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model…	DePuy Orthopaedics, Inc.	2009	—
+1	K101240	Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021…	DePuy Orthopaedics, Inc.	2010	—
+2	K113014	Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2012	12
+3	K121651	Ortholoc 3DI Midfoot/Flatfoot System	Wrightmedicaltechnologyinc	2012	—
+2	K132886	Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System	Smith & Nephew, Inc.	2014	2
+3	K140814	Evos Mini-Fragment Plating System	Smith & Nephew, Inc.	2014	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	4	0
2013	1	0
2014	9	0
2015	8	0
2016	5	0
2017	14	0
2018	10	0
2019	7	0
2020	14	0
2021	12	0
2022	11	0
2023	13	0
2024	20	0
2025	16	0
2026	10	0

FIG. 1 — Lineage of K091294, 2009–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (155)

See all 155

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

Number	Device	Applicant	Decided	Descendants
K101240	Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…	DePuy Orthopaedics, Inc.	2010	154
K131670	Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)	Biomet, Inc.	2013	5
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?

Of its descendants, K101240 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 154 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. 2009, 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 DePuy LCL and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091294: Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091294

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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