510(k) · Cleared

Cleared

Radial Nail System

K040938510(k) TraditionalCleared Jul 1, 200480-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 Jul 1, 2004 after an 80-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided: Jul 1, 2004
Review: 80 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

9 later devices descend from it, 3 citing it directly.

This deviceK040938 Radial Nail SystemWrightmedicaltechnologyinc · 2004
Descendant · cites it directly · 6 of its ownK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
Descendant · cites it directly · 4 of its ownK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
Descendant · 2 generations on · 2 of its ownK131552 Conventus DRSConventus Orthopaedics · 2014
Descendant · 2 generations on · 1 of its ownK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
Descendant · cites it directly · 1 of its ownK150073 MICRONAIL Distal Radius SystemWrightmedicaltechnologyinc · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 3 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all

K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008 · cites it directly6descendants
K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013 · cites it directly4descendants
K131552Conventus DRSConventus Orthopaedics · 2014 · 2 generations on2descendants
K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015 · 2 generations on1descendant
K150073MICRONAIL Distal Radius SystemWrightmedicaltechnologyinc · 2015 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K040938	Radial Nail System	Wrightmedicaltechnologyinc	2004	—
+1	K071809	Ensplintrx Bone Fixation System	Sonoma Orthopedic Products, Inc.	2008	—
+1	K102689	Conventus Orthopaedics Fracture Fixation System	Conventus Orthopaedics	2013	—
+2	K131552	Conventus DRS	Conventus Orthopaedics	2014	—
+2	K151379	Conventus PRS System	Conventus Orthopaedics, Inc.	2015	—
+1	K150073	MICRONAIL Distal Radius System	Wrightmedicaltechnologyinc	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2013	1	0
2014	1	0
2015	3	0
2016	1	0
2026	1	0

FIG. 1 — Lineage of K040938, 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
*	—	LOCON-T® Distal Radial Plating System Named without a submission number			—

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K071809	Ensplintrx Bone Fixation System	Sonoma Orthopedic Products, Inc.	2008	6
K102689	Conventus Orthopaedics Fracture Fixation System	Conventus Orthopaedics	2013	4
K150073	MICRONAIL Distal Radius System	Wrightmedicaltechnologyinc	2015	1

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, K071809 (Sonoma Orthopedic Products, Inc., 2008) has gone furthest, with 6 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 Radial Nail System is intended to be used for the 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;

* 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040938 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040938: Radial Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040938

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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