The CHARLOTTE™ MTP Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.

Indications for Use:

· Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
· Deformity due to hallux valgus
· Deformity due to arthritis in the first metatarsal-phalangeal joint
Loss of motion- hallux rigidus
· Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
· Revision procedures where other treatments or devices have failed: and
· Chronic instability in the first metatarsal-phalangeal joint

Device Description

The CHARLOTTE™ MTP Bone Fusion Plate System consists of plates in left and right configurations and screws. All screws and plates are manufactured from stainless steel (ASTM F138).

The design features and function of the screws included in the CHARLOTTE™ MTP Bone Fusion Plate System are substantially equivalent to the design features previously cleared under the Bone Fusion Plate (renamed and from here on referred to as: CHARLOTTETM MTP Bone Fusion Plate System). The system includes 2.7mm and 3.7mm screws in lengths from 8mm to 24mm.

AI/ML Overview

The provided document is a 510(k) summary for the CHARLOTTE™ MTP Bone Fusion Plate System, intended to demonstrate substantial equivalence to a predicate device. This type of regulatory submission does not typically include clinical studies or data on AI/human performance. Instead, it relies on non-clinical evidence (mechanical testing) and a comparison of technological characteristics to show that the new device is as safe and effective as a previously cleared device.

Therefore, many of the requested items related to acceptance criteria, specific study designs, human reader performance, training data, and ground truth establishment (which are common for AI/ML device submissions) are not applicable to this document.

Here's an analysis based on the information provided:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence: Performance of subject screw is statistically equivalent or greater than the predicate screw in Torsional Yield Strength per ASTM F543-02.	The mechanical testing, including Torsional Yield Strength per ASTM F543-02, has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw.
Technological Characteristics: Identical indications for use, same overall features, identical material.	The CHARLOTTE™ MTP Bone Fusion Plate System and the legally marketed predicate CHARLOTTE™ MTP Bone Fusion Plate System Screw have identical indications, have the same overall features, and are identical in material.
Safety and Effectiveness: No new types of questions of safety or effectiveness.	The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted, the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.

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

Not applicable. The document describes mechanical testing of components, not a clinical test set with patient data.

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. This pertains to clinical data review, which was not part of this 510(k) submission.

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

Not applicable. No clinical test set.

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

No, not done. This is a medical device (plate and screw system), not an AI/ML diagnostic aid. Clinical effectiveness studies are not typically required for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means. The document explicitly states "N/A" for "Substantial Equivalence- Clinical Evidence."

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" or reference for performance was established by ASTM F543-02 standard and the performance of the predicate screw.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

Summary

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JUL 0 9 2014

Headquarters Wright Medical Technology, inc.

1023 Cherry Road Memphls, TN 38117

901 867 9971 wmt.com

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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CHARLOTTE™ MTP Bone Fusion Plate System.

Submitted Bv:

Date:

Contact Person:

June 10, 2014

5677 Airline Road Arlington, TN 38002

Leslie Fitch Senior Regulatory Affairs Specialist Office (901) 867-4120 (901) 867-4190 Fax

Wright Medical Technology, Inc.

Proprietary Name:

Common Name:

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CHARLOTTE™ MTP Bone Fusion Plate System

Single/Multiple Component Metallic Bone Fixation Appliances and Accessories

Classification Name and Reference:

Device Product Code, Device Panel:

K042205 Bone Fusion Plate

HRS - Orthopedic

21 CFR 888.3030- Class II

Predicate Device:

ﻪ ﻪ ﺩ

Device Description

The CHARLOTTE™ MTP Bone Fusion Plate System consists of plates in left and right configurations and screws. All screws and plates are manufactured from stainless steel (ASTM F138).

Pg.1/2

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K141417

5. Intended Use

Indications for Use:

· Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
· Deformity due to hallux valgus
· Deformity due to arthritis in the first metatarsal-phalangeal joint
Loss of motion- hallux rigidus

· Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint

· Revision procedures where other treatments or devices have failed: and
· Chronic instability in the first metatarsal-phalangeal joint

Technological Characteristics Comparison

The CHARLOTTE™ MTP Bone Fusion Plate System and the legally' marketed predicate CHARLOTTE™ MTP Bone Fusion Plate System Screw have identical indications. have the same overall features, and are identical in material. The only difference is the driver interface change in the head of the screw and the addition of parts provided sterile. There have been no changes to the plates and the compatibility is unchanged from the predicate.

7. Substantial Equivalence- Non-Clinical Evidence

Mechanical testing, including Torsional Yield Strength per ASTM F543-02, has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw.

8. Substantial Equivalence- Clinical Evidence

N/A

9. Substantial Equivalence- Conclusions

The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public I lealth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

July 9, 2014

Wright Medical Technology, Inc. Dr. Leslie Fitch Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

Re: K141417

Trade/Device Name: CHARLOTTE MTP Bone Fusion Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 10, 2014 Received: June 16, 2014

Dear Dr. Fitch:

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 enacunent 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Leslie Fitch

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K141417

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K141417

Device Name

CHARLOTTE™ MTP Bone Fusion Plate System

Indications for Use (Describe)

Indications for Use:

· Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
Deformity due to hallux valgus
· Deformity due to arthritis in the first metatarsal-phalangeal joint
· Loss of motion- hallux rigidus
· Pain associated with ostcoarthritis or rheumatoid arthritis in the first metatarsal-phalangeal

joint · Revision procedures where other treatments or devices have failed; and

· Chronic instability in the first metatarsal-phalangeal joint

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Commend Court Court Court Course Procession Concession Compressional Concession Compression Compression Company Company Company Company Company Company Company Company Compan------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Comments of the contribution of the submitted on the status and the manufacturer of the manufacturer of the many of the many of the many of the many of the many of the many o

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY. . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth||読底rank -S

Division of Orthopedic Devices

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.