510(k) · Cleared

Cleared

Synthes (Usa) Locking Condylar Plate (LCP) System

K000066510(k) TraditionalCleared Mar 15, 200065-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Mar 15, 2000 as substantially equivalent to K982222 (Synthes (Usa), 1998) after a 65-day review. Its family tree reaches back 1 generation to 1998. 1 of the 715 devices in its family, counting itself, has a Class I recall. 713 later devices descend from it.

Decided: Mar 15, 2000
Review: 65 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982222 (1998). 713 later devices descend from it, 9 citing it directly. 1 of the 715 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK982222 Synthes (Usa) Distal Femur Plate (DFP) SystemSynthes (Usa) · 1998
This deviceK000066 Synthes (Usa) Locking Condylar Plate (LCP) SystemSynthes (Usa) · 2000
Descendant · cites it directly · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
Descendant · 2 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
Descendant · 2 generations on · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
Descendant · 2 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009

Showing 5 of 713 descendants. See all descendants

Descendants cleared per year

2002high 73 (2026) · low 1 (2002)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 713 · See all

K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · cites it directly690descendants
K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 2 generations on584descendants
K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · 2 generations on501descendants
K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 2 generations on495descendants
K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982222	Synthes (Usa) Distal Femur Plate (DFP) System	Synthes (Usa)	1998	—
0 (this device)	K000066	Synthes (Usa) Locking Condylar Plate (LCP) System	Synthes (Usa)	2000	—
+1	K033669	Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)	Smith & Nephew, Inc.	2003	1
+2	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
+2	K062216	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2006	1
+2	K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	—
+2	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	3	0
2005	6	0
2006	6	0
2007	6	0
2008	6	0
2009	9	0
2010	11	0
2011	18	0
2012	20	0
2013	25	0
2014	39	0
2015	39	0
2016	30	0
2017	51	0
2018	31	0
2019	36	0
2020	41	0
2021	47	1
2022	40	0
2023	50	0
2024	65	0
2025	59	0
2026	73	0

FIG. 1 — Lineage of K000066, 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.

1 device in this family has a Class I recall. 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? (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
*	K982222	Synthes (Usa) Distal Femur Plate (DFP) System Summary page 1 …CLASSIFICATION: PREDICATE DEVICE: Synthes FemurPlate Distal (DFP)System, (K982222) DESCRIPTION: SynthesLCP Systemisa plateandscrewsystem.…	Synthes (Usa)	1998	—

Also cleared against K982222: 2 other devices →

What descends from it? (713)

See all 713

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

Number	Device	Applicant	Decided	Descendants
K033669	Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)	Smith & Nephew, Inc.	2003	690
K110354	4.5MM VA-LCP Curved Condylar Plate System	Synthes USA	2011	62
K042598	Periarticular Locking Plates and Screws, 2357 and 2359 Series	Zimmer, Inc.	2004	31
K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	7
K192745	DePuy Synthes Trauma Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2019	5
K042237	Ebi Periarticular Plating System	Ebi, L.P.	2004	3
K140119	Emerge Medical Periarticular and Locking Large Fragment System	Emerge Medical	2014	1
K190750	DePuy Synthes Plates and Screws Portfolio	DePuy Synthes	2019	0
K111891	Synthes Brainlab Trauma Compatible Instruments	Synthes (USA) Products, LLC	2011	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K033669 (Smith & Nephew, Inc., 2003) has gone furthest, with 690 descendants of its own.
2 other devices also cite its predicate K982222.

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?

Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

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/K000066 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000066: Synthes (Usa) Locking Condylar Plate (LCP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000066

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026