510(k) · Cleared

Recalled · Class II · 2020

Synths One-Third Tubular DCL Plate

K011335510(k) TraditionalCleared Jul 27, 200186-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Jul 27, 2001 as substantially equivalent to K000684 (Synthes (Usa), 2000) after an 86-day review. Its family tree reaches back 1 generation to 2000. 1 of the 842 devices in its family, counting itself, has a Class I recall. 840 later devices descend from it. It has been recalled 2 times.

Decided: Jul 27, 2001
Review: 86 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K000684 (2000). 840 later devices descend from it, 43 citing it directly. 1 of the 842 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
This deviceK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001
Descendant · cites it directly · 792 of its ownK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · 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 · cites it directly · 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
Descendant · 2 generations on · 280 of its ownK021626 Hallu PlatesNew Deal, S.A. · 2002

Showing 5 of 840 descendants. See all descendants

Descendants cleared per year

2001high 83 (2026) · low 1 (2001)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 840 · See all

K012655Congruent Bone Plate SystemAcu Med, Inc. · 2001 · cites it directly792descendants
K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 2 generations on584descendants
K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · cites it directly495descendants
K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
K021626Hallu PlatesNew Deal, S.A. · 2002 · 2 generations on280descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
0 (this device)	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	—
+1	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
+2	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
+1	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	—
+2	K021626	Hallu Plates	New Deal, S.A.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	1	0
2004	2	0
2005	9	0
2006	8	0
2007	6	0
2008	4	0
2009	7	0
2010	12	0
2011	23	0
2012	24	0
2013	29	0
2014	45	0
2015	49	0
2016	32	0
2017	67	0
2018	35	0
2019	42	0
2020	53	0
2021	53	1
2022	51	0
2023	57	0
2024	75	0
2025	70	0
2026	83	0

FIG. 1 — Lineage of K011335, 2000–2026Source: 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? (2)

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
*	K000684	Small Fragment Dynamic Compression Locking (DCL) System Summary page 1 …e-Amendment) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) Device Description Synthes One-Third Tubular DCL Plate line extension is a threaded…	Synthes (Usa)	2000	1
*	—	Synthes Third Tubular Plate (Pre-Amendment) Named without a submission number			—

Also cleared against K000684: 68 other devices →

What descends from it? (840)

See all 840

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

Number	Device	Applicant	Decided	Descendants
K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	792
K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	495
K112437	Arthrex Fracture System	Arthrex, Inc.	2011	91
K102282	The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2010	77
K120070	Synthes Variable Angle LCP Elbow System	Synthes USA	2012	76
K123241	Arthrex Fracture Plates	Arthrex, Inc.	2013	71
K120854	Synthes VA LCP Ankle Trauma System	Synthes USA	2012	44
K063672	Fibula Plate Prolock with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2007	25
K143385	Acumed Ankle Plating System	Acumed, LLC	2015	23
K143394	Acumed Small Fragment Base Set	Acumed, LLC	2015	18

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 21, 2020	Class II	Z-2816-2020	Process control	May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an…
Feb 22, 2013	Class II	Z-1557-2013	Under Investigation by firm	The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.

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 a recall.
Of its descendants, K012655 (Acu Med, Inc., 2001) has gone furthest, with 792 descendants of its own.
68 other devices also cite its predicate K000684.

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 One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K011335 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011335: Synths One-Third Tubular DCL Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011335

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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