510(k) · Cleared

Cleared

Locon-T Distal Radial Plate

K994061510(k) TraditionalCleared Feb 14, 200075-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

Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone

Cleared on Feb 14, 2000 after a 75-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided: Feb 14, 2000
Review: 75 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK994061 Locon-T Distal Radial PlateWrightmedicaltechnologyinc · 2000
Descendant · cites it directly · 7 of its ownK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
Descendant · cites it directly · 6 of its ownK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
Descendant · 2 generations on · 4 of its ownK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
Descendant · 3 generations on · 2 of its ownK131552 Conventus DRSConventus Orthopaedics · 2014
Descendant · 3 generations on · 1 of its ownK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004high 2 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all

K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004 · cites it directly7descendants
K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008 · cites it directly6descendants
K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013 · 2 generations on4descendants
K131552Conventus DRSConventus Orthopaedics · 2014 · 3 generations on2descendants
K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K994061	Locon-T Distal Radial Plate	Wrightmedicaltechnologyinc	2000	—
+1	K042437	Dorsal Intramedullary Plate	Deo Volente Orthopaedics, LLC	2004	—
+1	K071809	Ensplintrx Bone Fixation System	Sonoma Orthopedic Products, Inc.	2008	—
+2	K102689	Conventus Orthopaedics Fracture Fixation System	Conventus Orthopaedics	2013	—
+3	K131552	Conventus DRS	Conventus Orthopaedics	2014	—
+3	K151379	Conventus PRS System	Conventus Orthopaedics, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2009	1	0
2013	1	0
2014	1	0
2015	2	0
2016	1	0

FIG. 1 — Lineage of K994061, 2000–2016Source: 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
*	—	Zimmer Forte Distal Radial Plate System Named without a submission number			—

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K042437	Dorsal Intramedullary Plate	Deo Volente Orthopaedics, LLC	2004	7
K071809	Ensplintrx Bone Fixation System	Sonoma Orthopedic Products, Inc.	2008	6

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, K042437 (Deo Volente Orthopaedics, LLC, 2004) has gone furthest, with 7 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?

Use of the LoCon-T Distal Radial Plate System is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable: Joint destruction and/or subluxation visible on x-ray; Failed fracture fixation with or without bone graft; Osteotomy and repair of distal radius malunion with or without bone graft; Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone; Dorsal…

Read the full statement (119 words)

Use of the LoCon-T Distal Radial Plate System is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable:

Joint destruction and/or subluxation visible on x-ray;

Failed fracture fixation with or without bone graft;

Osteotomy and repair of distal radius malunion with or without bone graft;

Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;

Dorsal plates are indicated for use with comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; or

T-plates are indicated for use with volar articular shearing fractures

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/K994061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994061: Locon-T Distal Radial Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994061

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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