(90 days)
Not Found
Not Found
No
The device description focuses solely on the mechanical components (plates and screws) and their physical properties and design features. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No.
The device is an orthopedic implant for fixation of unstable radius fractures, which is a structural device, not a therapeutic device.
No
Explanation: The device is an implant for fixing unstable radius fractures, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (plates, cortical screws, locking screws) made of stainless steel, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of unstable radius fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws, which are implants used to stabilize bone fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The EVOLVE® Radial Plate is indicated for fixation of unstable radius fractures in which closed reduction is not suitable.
Product codes
HRS
Device Description
The EVOLVE® Radial Plate system consists of plates, cortical screws, and locking screws.
Plates are manufactured from stainless steel, offered in two lengths (Short and Long), have a cupped head with varying arch to accommodate patient's anatomy, compression slots to facilitate uniting a fracture, threaded screw holes in the head portion to accept locking screws for stable plate/screw construct, and cortical screw holes located in head and shaft.
Cortical Screws are manufactured from stainless steel, available in two diameters (2.7mm and 1.8mm) in varying lengths ranging from 3.0mm to 40.0mm in 2mm increments.
Locking Screws are manufactured from stainless steel, available in lengths from 14mm to 28mm in 2mm increments, and have threads on the screw that mate to threads in the screw holes to fix the screw to the plate, reducing the likelihood of screw loosening and improving the screw to plate stability of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
LOCON-T® Distal Radial Plating System
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 a date, which is January 28, 2004. The text is written in a simple, sans-serif font. The numbers are clearly legible. The image is a close-up of the date.
િઝ્ટર્ડ્યર્ડદ
Image /page/0/Picture/1 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design consisting of three horizontal lines that are angled slightly downward, creating a sense of depth. The letters are large and spaced closely together, giving the word a strong visual presence. The letters "TM" are located at the bottom right of the image.
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 EVOLVE® Radial Plate.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | October 28, 2003 |
| Contact Person: | Katie Logerot |
| Regulatory Affairs Associate | |
| Proprietary Name: | EVOLVE® Radial Plate |
| Common Name: | Radial Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3030 Plate, Fixation, Bone - Class D |
DEVICE INFORMATION
A. INTENDED USE
The EVOLVE® Radial Plate is indicated for fixation of unstable radius fractures in which closed reduction is not suitable.
B. DEVICE DESCRIPTION
The EVOLVE® Radial Plate system consists of plates, cortical screws, and locking screws. The design features of the plates and locking screws of the EVOLVE® Radial Plate system are summarized below:
Plates
- . Manufactured from stainless steel
- Offered in two lengths: Short and Long .
- Cupped head with varying arch to accommodate patient's anatomy .
Arlinaton, TN 3800
- Compression slots compress fracture as screw is tightened to facilitate uniting a fracture .
- Threaded screw holcs in the head portion accept locking screws for stable plate/screw . construct
- Cortical screw holes located in head and shaft .
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headquarters international subsidiance
011.32.2.378.3905 Belg
The state of the state of the state of the section and works and
Wright Medical Technology, Inc.
905.826.1600 Canada
011.81.3.3538.0474 Japan
33.1.45.13.24.40 France
.wmt.com
.404 UK
.49.4161.745130 Germany
1
KB33456
Cortical Screws
- Manufactured from stainless stecl .
- Available in two diameters: 2.7mm and 1.8mm in varying lengths ranging from 3.0mm to . 40.0mm in 2mm increments
- Identical to cortical screws previously submitted and cleared under the LOCON-T® . Distal Radial Plating System
Locking Screws
- Manufactured from stainless steel �
- Available in lengths from 14mm to 28mm in 2mm increments .
- Threads on the screw mate to threads in the screw holes to fix the screw to the plate . reducing the likelihood of screw loosening and improving the screw to plate stability of the system
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the EVOLVE® Radial Head Plate are substantially equivalent to previously cleared plating systems. The safety and effectiveness of the EVOLVE® Radial Head Plate are adcquately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol with three intertwined snakes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2004
Ms. Katie Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K033456
Trade/Device Name: EVOLVE Radial Plate 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: October 28, 2003 Received: October 30, 2003
Dear Ms. Logerot:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becternined 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 encreations of 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. de rices that have been require approval of a premarket approval application (PMA). and Cosmette rear (110-) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, mains of the Act include requirements for annual registration. Iisting of general controls profitering 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial cquivalence determination does not mean I lease of advisourined i betermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. , You must or any I coural all the Act's requirements, including, but not limited to: registration and listing (2 l 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. product rachation of control to begin marketing your device as described in your Section 510(k) rms tetter will and in your your substantial equivalence of your device to a legally
3
Page 2 – Ms. Katie Logerot
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 ir you aton office of Compliance at (301) 594-4659. 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 minternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(501) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sincerely vours,
Sincerely, yours,
Mark McMullen
Celia M. Witten, Ph.D., M.D. Division 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): K033456
Device Name:_EVOLVE® Head Plate
Indications For Use:
The EVOLVE® Radial Plate is indicated for fixation of unstable radius fractures in which closed reduction is not suitable.
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)
f Mark N Mulkern
Restorative
ological Devices
K033456
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