(24 days)
Not Found
Not Found
No
The device description and intended use are for a mechanical implant (plate and screws) used for bone fusion. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended to assist in bony union and maintain toe position during fusion for various conditions like fractures, deformities, and pain, fitting the definition of a therapeutic device.
No
The device is a fusion plate intended to help increase the rate of bony union and maintain the position of the toe during fusion, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of plates and screws, 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 and Intended Use: The CHARLOTTE™ Small MTP Fusion Plate is a physical implant designed to be surgically placed in the body to stabilize and promote the fusion of bones in the foot. It does not perform any tests on bodily samples.
The information provided clearly describes a surgical implant used for orthopedic procedures, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The CHARLOTTE™ Small MTP Fusion Plate 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 hallus 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 metatarsal-phalangeal 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™ Small MTP Fusion Plate consists of plates, and previously cleared screws. The design features of the CHARLOTTE™ Small MTP Fusion Plate are summarized below:
Plate
- · Manufactured from ASTM F139
- Left and Right configurations
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
WMT's Bone Fusion Plate
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
K051884 p1/2
AUG 5 - 2005
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in all capital letters. Below the word is a graphic of what appears to be a stylized letter "W". In the bottom right corner of the image is the trademark symbol.
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 CHARLOTTE™ Small MTP Fusion Plate.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | July 11, 2005 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist | |
| Proprietary Name: | CHARLOTTE™ Small MTP Fusion Plate |
| Common Name: | Bone Fusion Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HRS |
DEVICE INFORMATION
A. INTENDED USE
The CHARLOTTE™ Small MTP Fusion Plate 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 hallus 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 metatarsal-phalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint
headquarters
Wright Medical Technology, Inc. 5677 Airline Road
J
Arlington. TN 38002 901.867.9971 phone www.wmt.com
international subsidiarie. 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
011.81.3.3538.0474 Japan
011-33-1-45-13-24-40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany
1
K0:8541 p½
B. DEVICE DESCRIPTION
The CHARLOTTE™ Small MTP Fusion Plate consists of plates, and previously cleared screws. The design features of the CHARLOTTE™ Small MTP Fusion Plate are summarized below:
Plate
- · Manufactured from ASTM F139
- Left and Right configurations
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the CHARLOTTE™ Small MTP Fusion Plate are substantially equivalent to WMT's Bone Fusion Plate. The safety and effectiveness of the CHARLOTTE™ Small MTP Fusion 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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wesley L. Reed Regulatory Affairs Specialist _________ 5677 Airline Road Arlington, Tennessee 38002
e,,
Re: K051884 KU31884
Trade/Device Name: CHARLOTTE™ Small MTP Bone Fusion Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 11, 2005 Received: July 12, 2005
AUG 5 - 2005
Dear Mr. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of the enactment date of the Medical Device Amendments, or to commerce pror to that 2011-17, in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110-) that to device, subject to the general controls provisions of the Act. The 1 ou may, dicrolore, manes of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is elassinod (tional controls. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease be activised that I Drivice and that your device complies with other requirements of the Act that I DI has intates and regulations administered by other Federal agencies. You must of any I odefar statutes and equirements, 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 (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 -Mr. Wesley L. Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lett notification. The FDA finding of substantial equivalence of your device to a legally prematics notification "The 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 If you don't office of Compliance at (240) 276-0120. 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 other general miletimational 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,
Hyde Rlurdu
Mark N. Melkerson Acting 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: CHARLOTTE™ Small MTP Bone Fusion Plate System
Indications For Use:
The CHARLOTTE™ Small MTP Bone Fusion Plate System is intended to help The CHARLOT TE - Omail wa, and to maintain the position of the toe during fusion. increase the fato of bony athe is secondary in the transmission of gait forces.
Indications for Use:
- Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- Deformity due to hallus 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
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 CDRHz Office of Device Evaluation (ODE)
Stypk Hurda
1 of 1
(Division Sign-Off Division of General, Perforative, and Neurological Devices
510(k) Number_