510(k) · Cleared

Recalled · Class II · 2018

Distal Volar Radius Plating Systems

K112345510(k) TraditionalCleared Oct 31, 201177-day reviewClass II21 CFR 888.3030Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medos International SARL · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Oct 31, 2011 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled 4 times.

Decided: Oct 31, 2011
Review: 77 days
Class: Class II
Product code: LXT
Recalls: 4
Predicates: 0

17 later devices descend from it, 4 citing it directly.

This deviceK112345 Distal Volar Radius Plating SystemsMedos International SARL · 2011
Descendant · cites it directly · 11 of its ownK133939 Modified Distal Radius Plating SystemBiomet · 2014 · Recalled
Descendant · 2 generations on · 10 of its ownK161665 VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016
Descendant · 3 generations on · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
Descendant · 3 generations on · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
Descendant · 3 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2013high 3 (2026) · low 0 (2015)2026

Most influential descendants

Showing 5 of 17 · See all

K133939Modified Distal Radius Plating SystemBiomet · 2014 · cites it directly11descendants
K161665VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016 · 2 generations on10descendants
K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018 · 3 generations on9descendants
K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · 3 generations on7descendants
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K112345	Distal Volar Radius Plating Systems	Medos International SARL	2011	—
+1	K133939	Modified Distal Radius Plating System	Biomet	2014	2
+2	K161665	VLP Wrist Fracture System	Smith & Nephew, Inc.	2016	—
+3	K181533	EVOS Wrist Fracture Plating System	Smith & Nephew, Inc.	2018	—
+3	K210837	Smith & Nephew Plates and Screws	Smith & Nephew, Inc.	2021	1
+3	K213126	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…	Smith & Nephew, Inc.	2022	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	2	0
2016	2	0
2018	1	0
2019	1	0
2021	1	0
2022	2	0
2023	2	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K112345, 2011–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXT? 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 LXT device

#1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K133939	Modified Distal Radius Plating System	Biomet	2014	11
K132704	Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow	Biomet	2013	2
K162424	Ulna Plating System	Biomet, Inc.	2016	0
K140622	DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna Plate	Biomet, Inc.	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 20, 2018	Class II	Z-0708-2019	Packaging process control	One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Nov 20, 2018	Class II	Z-0709-2019	Packaging process control	One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Jan 29, 2016	Class II	Z-1082-2016	Package design/selection	Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a…
Mar 18, 2015	Class II	Z-1446-2015	Nonconforming Material/Component	A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K133939 (Biomet, 2014) has gone furthest, with 11 descendants of its own.

How does its category compare?

All LXT devices

LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LXT

1in 2023

2007high 2 (2013) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXT

Too few LXT 510(k)s in any year since 2007 to give a median.

Recalls per year · LXT

2in 2018

2007high 7 (2009) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LXT

7in 2025

2007high 85 (2011) · low 7 (2025)2025

MAUDE reports naming product code LXT, 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	1	—	1	26
2008	1	—	0	58
2009	1	—	7	41
2010	0	—	0	33
2011	1	—	0	85
2012	0	—	0	42
2013	2	—	0	39
2014	0	—	0	36
2015	0	—	0	35
2016	0	—	0	38
2017	0	—	0	66
2018	0	—	2	73
2019	0	—	0	40
2020	0	—	0	32
2021	0	—	0	24
2022	0	—	0	21
2023	1	—	0	18
2024	0	—	0	27
2025	0	—	0	7
2026	0	—	0	—

https://510kreport.com/device/K112345 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112345: Distal Volar Radius Plating Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112345

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026