(27 days)
Not Found
No
The summary describes a mechanical compression plate and screws for bone fixation, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a "Compression Plate" intended for "fixation" within the foot, which categorizes it as a surgical implant for structural support, not a device directly involved in therapy or treatment beyond mechanical stabilization.
No
The device is described as a fixation plate for surgical procedures and does not mention any diagnostic capabilities. Its intended uses are for surgical fixation of bones, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components (plates and screws) made of stainless steel, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for fixation of bones during surgical procedures (arthrodesis, osteotomies). This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a plate and screws made of stainless steel. This is consistent with a surgical implant used for structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
The product has been cleared via the traditional 510(k) pathway.
Intended Use / Indications for Use
The CHARLOTTE™ Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Product codes
HRS
Device Description
The CHARLOTTE™ Compression Plate consists of 3 sizes of plates and 2.7mm lockingscrews varying in length from 12mm to 24mm. All plates and screws are manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
LisFranc, forefoot, first metatarsophalangeal, midfoot, hindfoot, metatarsocuneiform 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)
Not Found
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
Image /page/0/Picture/0 description: The image shows the word "WRIGHT." in large, bold, black letters. Above the word, there is handwritten text that reads "K051908 page 1 of 1". Below the word "WRIGHT.", there is a graphic of three black triangles pointing upwards, arranged in a row. The letters "TM" are located below the triangles.
AUG 1 0 2005
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 CHARLOTTE™ Compression Plate.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | July 11, 2005 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist | |
| Proprietary Name: | CHARLOTTET™ Compression Plate |
| Common Name: | Compression Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone -- Class II |
| Device Product Code and Panel Code: | Orthpedics/87/HRS |
DEVICE INFORMATION
A. INTENDED USE
The CHARLOTTE™ Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
B. DEVICE DESCRIPTION
The CHARLOTTE™ Compression Plate consists of 3 sizes of plates and 2.7mm lockingscrews varying in length from 12mm to 24mm. All plates and screws are manufactured from stainless steel.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the CHARLOTTE™ Compression Plate are substantially equivalent or identical to the previously cleared Compression Staple (K043059). The safety and effectiveness of the CHARLOTTE™ Compression Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
headquarters
Wright Medical Technology, Inc. 5677 Alrline Road Arlington, TN 38002 901.867.9971 phon www.wmt.com international subsidiaries 011.32.2.378.3905 Belgium 905.826.1600 Canada 011.33.1.45.13.24.40 France 011.49.4161.745130 Germany 011.39.0250.678.227 Italy 011.81.3.3538.0474 lanar 011.44.1483.721.404 | |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming the body and wings, and two curved lines representing the legs and feet.
AUG 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K051908 Trade/Device Name: CHARLOTTE™ Compression Plate 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 14, 2005
Dear Mr. Reed:
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.
2
Page 2 - Mr. Wesley L. Reed
This letter will allow you to begin marketing your device as described in your Section 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), please contact the 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 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,
Stipta Rlwdn
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: CHARLOTTE™ Compression Plate
Indications For Use:
The Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
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)
1 of 1
Stypt Lurdu
I. Generet, Restorative S Nevrological Devices
KOS1908