(41 days)
Not Found
No
The device description and intended use clearly define a mechanical bone fusion plate system made of stainless steel. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to help increase the rate of bony union and maintain toe position during fusion for various joint conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is intended to increase bony union and maintain bone position during fusion, addressing conditions like fractures, deformities, and arthritis. It is a treatment device, not one used for diagnosis.
No
The device description explicitly states that the system consists of plates and screws manufactured from stainless steel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The CHARLOTTE™ MTP Bone Fusion Plate System is a physical implantable device (plates and screws) made of stainless steel. It is surgically implanted to stabilize and fuse bones in the foot.
- Intended Use: The intended use is to physically support and stabilize the first metatarsal-phalangeal joint during the fusion process. It does not involve testing biological samples.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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
Product codes
HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsal-phalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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).
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.
Pg.1/2
1
K141417
5. Intended Use
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
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.
2
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
3
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
4
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
Device Name
CHARLOTTE™ MTP Bone Fusion Plate System
Indications for Use (Describe)
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 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
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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