510(k) · Cleared

Cleared

Synthes Low Profile Reconstruction Plates

K042377510(k) TraditionalCleared Oct 7, 200436-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 Oct 7, 2004 after a 36-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.

Decided: Oct 7, 2004
Review: 36 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

17 later devices descend from it, 6 citing it directly.

This deviceK042377 Synthes Low Profile Reconstruction PlatesSynthes (Usa) · 2004
Descendant · cites it directly · 5 of its ownK142836 Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc. · 2014
Descendant · cites it directly · 4 of its ownK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
Descendant · 2 generations on · 4 of its ownK143331 Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc. · 2015
Descendant · cites it directly · 2 of its ownK221809 DePuy Synthes 3.5mm Intrapelvic Acetabular SystemDePuy Synthes · 2022
Descendant · 3 generations on · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2005high 3 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 17 · See all

K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc. · 2014 · cites it directly5descendants
K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly4descendants
K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc. · 2015 · 2 generations on4descendants
K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemDePuy Synthes · 2022 · cites it directly2descendants
K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K042377	Synthes Low Profile Reconstruction Plates	Synthes (Usa)	2004	—
+1	K142836	Zimmer Plates and Screws (ZPS), Forte Screws	Zimmer, Inc.	2014	—
+1	K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	—
+2	K143331	Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS	Zimmer, Inc.	2015	—
+1	K221809	DePuy Synthes 3.5mm Intrapelvic Acetabular System	DePuy Synthes	2022	—
+3	K171320	ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws…	Meril Healthcare Pvt., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2014	1	0
2015	2	0
2018	2	0
2019	1	0
2020	2	0
2022	2	0
2024	1	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K042377, 2004–2026Source: 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 Reconstruction Plates Named without a submission number			—

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K142836	Zimmer Plates and Screws (ZPS), Forte Screws	Zimmer, Inc.	2014	5
K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	4
K221809	DePuy Synthes 3.5mm Intrapelvic Acetabular System	DePuy Synthes	2022	2
K201229	Intai Anatomic Locking Plate and Screw System	Intai Technology Corporation	2022	0
K200295	IlluminOss Bone Stabilization System	Illuminoss Medical, Inc.	2020	0
K051155	Solco 4CIS General Plate System	Solco Biomedical Co., Ltd.	2005	0

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, K142836 (Zimmer, Inc., 2014) has gone furthest, with 5 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?

The Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042377 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042377: Synthes Low Profile Reconstruction Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042377

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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