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;
Volar 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;
Locking volar plates are indicated for use with volar articular shearing fractures .

Device Description

The LOCON™ VLS Distal Radius Plate System consists of plates, cortical screws, and cancellous screws. The design features of the plates and screw components are summarized below:
Plates

Manufactured from stainless steel .
Offered in two lengths: Standard and Long .
Left and right configurations .
Locking and non-locking screw holes in distal portion .
Cortical screw holes located in proximal portion .
Compression slot feature in proximal portion .
K-wire holes in head and shaft t
Cupped head with varying arch to accommodate patient's anatomy .
Cortical Screws
Manufactured from stainless steel .
Available with 3.5mm diameter in lengths from 12mm- 20mm .
Cancellous Screws
Manufactured from stainless steel .
Available in two designs: standard and locking .
Standard screws are available with 2.7mm diameter in lengths from 12 26mm in 2mm . increments
Locking screws are available with 2.7mm diameter in lengths from 14 26mm in 2mm t increments

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the LOCON™ VLS Distal Radius Plate. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria demonstrated through a clinical study with performance metrics.

Therefore, many of the requested elements regarding acceptance criteria and study details are not present in this document, as they are not typically part of a 510(k) for a Class II bone fixation plate. The document focuses on demonstrating that the new device is fundamentally similar in design, materials, and intended use to an existing device (LOCON-T® Distal Radial Plate System).

Here's an analysis of what information is and is not provided, based on your request:

1. A table of acceptance criteria and the reported device performance

Not provided. This document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or mechanical performance) or reported device performance metrics in that context. The "acceptance" in a 510(k) substantial equivalence determination is that the new device is as safe and effective as the predicate, based on similar design and materials, and not inferior.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. There is no mention of a "test set" in the context of a clinical performance study. The substantial equivalence relies on comparison of design features, materials, and indications for use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This information would be relevant for a study where expert review establishes truth, typically for diagnostic or image-analysis devices. This document is for a bone fixation plate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is relevant for AI or diagnostic imaging devices. The LOCON™ VLS Distal Radius Plate is a physical medical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is relevant for AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in the traditional sense. For a 510(k) of this nature, the "ground truth" or basis for safety and effectiveness is largely the established safety and effectiveness of the predicate device, supported by material characteristics (e.g., stainless steel properties) and design principles known for bone plates. No specific "ground truth" data from a study is presented here.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission.

Summary of Information from the Document:

The LOCON™ VLS Distal Radius Plate received 510(k) clearance (K042358) based on demonstrating substantial equivalence to the LOCON-T® Distal Radial Plate System.

The "acceptance criteria" for this 510(k) submission were met by demonstrating that:

The intended use of the LOCON™ VLS Distal Radius Plate is the same as the predicate device (fixation of unstable distal radial fractures).
The device description (materials, design features like plate lengths, screw types, hole configurations) are similar. The plates are manufactured from stainless steel and consist of plates, cortical screws, and cancellous screws.
The fundamental scientific technology has not changed relative to the predicate device.

The document states: "The safety and effectiveness of the LOCON™ VLS Distal Radius Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." However, the specific details of this "materials information, and analysis data" (e.g., mechanical testing results) are not included in this summary document.
The FDA's letter (Page 2-3 of the provided text) confirms that the device was found "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

Summary

{0}------------------------------------------------

K 042358

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LOCON™ VLS Distal Radius Plate.

Submitted By:	Wright Medical Technology, Inc.
Date:	August 30, 2004
Contact Person:	Jeanine H. Redden
	Regulatory Affairs Specialist II
Proprietary Name:	LOCONTM VLS Distal Radius Plate
Common Name:	Volar Plate
Classification Name and Reference:	21 CFR 888.3030 Plate, Fixation, Bone -- Class II
Device Product Code and Panel Code:	21 CFR 888.3030 Plate, Fixation, Bone -- Class II

DEVICE INFORMATION

A. INTENDED USE

The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial 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;
Volar 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;
Locking volar plates are indicated for use with volar articular shearing fractures .

B. DEVICE DESCRIPTION

The LOCON™ VLS Distal Radius Plate System consists of plates, cortical screws, and cancellous screws. The design features of the plates and screw components are summarized ﻨﻮ ・・・・・・・ below:

{1}------------------------------------------------

Plates

Manufactured from stainless steel .
Offered in two lengths: Standard and Long .
Left and right configurations .
Locking and non-locking screw holes in distal portion .
Cortical screw holes located in proximal portion .
Compression slot feature in proximal portion .
K-wire holes in head and shaft t
Cupped head with varying arch to accommodate patient's anatomy .

Cortical Screws

Manufactured from stainless steel .
Available with 3.5mm diameter in lengths from 12mm- 20mm .

Cancellous Screws

Manufactured from stainless steel .
Available in two designs: standard and locking .
Standard screws are available with 2.7mm diameter in lengths from 12 26mm in 2mm . increments
Locking screws are available with 2.7mm diameter in lengths from 14 26mm in 2mm t increments

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the LOCON™M VLS Distal Radius Plate System are substantially equivalent to the LOCON-T® Distal Radial Plate System. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the LOCON™ VLS Distal Radius Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UC1 ? ~ 2004

Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K042358 Trade/Device Name: LOCON™ VLS Distal Radius Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: August 30, 2004 Received: September 13, 2004

Dear Ms. Redden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 – Ms. Jeanine H. Redden

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyourse FDA finding of substantial equivalence of your device to a legally practed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: LOCON™ VLS Distal Radius Plate

Indications For Use:

The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial 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;
Volar 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;
Locking volar plates are indicated for use with volar articular shearing fractures .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milburn

of General. Restorative,

and Neurologica. Devices

510(k) Number

K042358

1 of 1

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.