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 extraarticular 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

Device Description

The LoCon-T Distal Radial Plate System includes four side specific dorsal plate, one volar T-plate, a dorsal plate extender, cortical screws, cancellous screws, and buttress pins. The plates and plate extender are manufactured from Stainless Steel (ASTM F 139). The screws are manufactured from Stainless Steel (ASTM F 138). The pins are manufactured from Stainless Steel (ASTM F 1314). The plates, pins, extender, and screws are designed to be lower in profile and secure bone fragments. The dorsal plates are available in two sizes for both right and left configurations. The cancellous screws are available in partially and fully threaded 4.0mm diameter designs ranging in length from 10.0 to 40.0mm in 2.0mm increments. The cortical screws are available in 3 diameters. The pins are 1.8mm in diameter and range in length from 12mm to 30mm.

AI/ML Overview

The provided text describes the 510(k) summary for the LoCon-T Distal Radial Plate System. It details the device, its intended use, and a summary of mechanical testing.

Acceptance Criteria and Study Details:

Based on the provided text, the acceptance criteria and study that proves the device meets them are focused on mechanical performance and substantial equivalence to a predicate device. This is typical for Class II medical devices like a metallic bone fixation system, where the primary concern is the device's physical integrity and comparability to already approved products.

Here's the breakdown of the requested information:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device	The LoCon-T Distal Radial Plate System was declared substantially equivalent to the predicate devices (Zimmer Forte Distal Radial Plate System).
Meets strength requirements of the predicate device	Mechanical test data demonstrated that the material and subject device design meets the strength requirements of the predicate device.
Material composition (Stainless Steel ASTM F 139, F 138, F 1314)	The plates and plate extender are manufactured from Stainless Steel (ASTM F 139). The screws are manufactured from Stainless Steel (ASTM F 138). The pins are manufactured from Stainless Steel (ASTM F 1314). (This is a design specification, implicitly met if materials were used as stated).
Design for lower profile and secure bone fragments	The plates, pins, extender, and screws are designed to be lower in profile and secure bone fragments. (This is a design specification, implicitly met if the design was followed).

Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the mechanical testing. It simply states "Mechanical test data." For mechanical testing of medical devices, sample size is often determined by engineering principles and statistical power calculations to ensure robust data.
- Data Provenance: The data provenance is derived from "Mechanical test data" supporting the 510(k) submission. The exact location or nature of this testing (e.g., in-house lab, third-party lab) is not specified, but it would have been part of the regulatory submission process in the USA (Arlington, TN is the company's address, and the submission is to the FDA in Rockville, MD). It is a prospective study in the sense that the testing was performed specifically to demonstrate compliance for this device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and testing. The "ground truth" for mechanical testing is established by engineering standards, material specifications (e.g., ASTM standards), and predefined strength requirements, not by expert consensus on clinical findings. The FDA reviewer, Neil RP Ogden, Acting Director Division of General and Restorative Devices, made the determination of substantial equivalence, which is a regulatory rather than a clinical ground truth establishment.
Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly those involving human interpretation of data (e.g., image analysis). For mechanical testing, the results are quantitative and objective measurements against predefined criteria, not subject to subjective adjudication in the same way.
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:
- No. An MRMC study is completely irrelevant here. This is a medical device (metallic bone fixation system) that is mechanically tested, not an AI or diagnostic imaging device that involves human interpretation of output.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is defined by engineering standards and pre-specified mechanical strength requirements derived from the predicate device and relevant industry standards for bone fixation systems. The predicate device (Zimmer Forte Distal Radial Plate System) itself serves as a benchmark for comparison regarding strength requirements.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a metallic orthopedic implant. Training sets are relevant for machine learning or AI models, which are not involved here.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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

FFB 1 4 2000

Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the name is the company's address: 5677 Airline Road, Arlington, TN 38002, and their phone number: 901-867-9971.

510K Summary

Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: November 30, 1999 Trade Name: LoCon-TTM Distal Radial Plate System Common Name: Metallic Bone Fixation System Predicate Device: Zimmer Forte Distal Radial Plate System

Description/Intended Use:

Intended Use:

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 extraarticular 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

Testing Summary:

The LoCon-T Distal Radial Plate System was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that the material and subject device design meets the strength requirements of the predicate device.

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

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2000

Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K994061 Trade Name: LoCon-T™ Distal Radial Plate System Regulatory Class: II Product Code: HRS Dated: November 30, 1999 Received: December 1, 1999

Dear Ms. Witkowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Ms. Lynne Witkowski

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil RP Ogden
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known)	K994061
Device Name	LoCon-T Distal Radial Plate System
Indications for Use

Intended Use

Use of the LoCon-T Distal Radial Plate System is intended for...

ystem is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable:

Indications for Use Statement

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	NRO for J2D
Division of General Restorative Devices
510(k) Number	K994061
Prescription Use (per 21 CFR 801.109)	X
	OR
	Over-The Counter Use

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.