510(k) · Cleared

Cleared

Synthes 3.5MM Spring Plate

K061973510(k) TraditionalCleared Sep 11, 200661-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 Sep 11, 2006 after a 61-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided: Sep 11, 2006
Review: 61 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

9 later devices descend from it, 2 citing it directly.

This deviceK061973 Synthes 3.5MM Spring PlateSynthes (Usa) · 2006
Descendant · cites it directly · 4 of its ownK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
Descendant · cites it directly · 3 of its ownK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · Recalled
Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
Descendant · 2 generations on · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
Descendant · 2 generations on · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2018high 3 (2026) · low 0 (2020)2026

Most influential descendants

Showing 5 of 9 · See all

K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly4descendants
K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · cites it directly3descendants
K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · 2 generations on1descendant
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061973	Synthes 3.5MM Spring Plate	Synthes (Usa)	2006	—
+1	K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	—
+1	K210935	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)	I.T.S. GmbH	2022	1
+2	K243995	Arthrex Humeral Plating System and Cerclage Button	Arthrex, Inc.	2025	—
+2	K190391	TDM Plate and Screw Systems	Tdm Co., Ltd.	2019	—
+2	K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with…	I.T.S. GmbH	2026	—

Descendants by year cleared

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

FIG. 1 — Lineage of K061973, 2006–2026Source: 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 One-Third Tubular LCP Plates, with collar Named without a submission number			—

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	4
K210935	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)	I.T.S. GmbH	2022	3

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, K180310 (Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., 2018) has gone furthest, with 4 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 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061973 · printed Nov 3, 2026

Cite this page

510(k) Report. “K061973: Synthes 3.5MM Spring Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061973

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