EVOLVE RADIAL PLATE

K033456 · Wrightmedicaltechnologyinc · HRS · Jan 28, 2004 · Orthopedic

Device Facts

• Record ID: K033456
• Device Name: EVOLVE RADIAL PLATE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVOLVE® Radial Plate is indicated for fixation of unstable radius fractures in which closed reduction is not suitable.

Device Story

The EVOLVE® Radial Plate is a bone fixation system consisting of stainless steel plates, cortical screws, and locking screws. The plates feature a cupped head with varying arches to accommodate patient anatomy, compression slots to facilitate fracture union, and threaded screw holes in the head to accept locking screws. The locking screws mate with the plate threads to provide a stable construct and reduce the risk of screw loosening. The device is intended for use by surgeons in a clinical setting to stabilize unstable radius fractures that cannot be managed via closed reduction. The system provides mechanical support to the bone during the healing process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technical analysis.

Technological Characteristics

Constructed from stainless steel. System includes plates (short/long), cortical screws (2.7mm and 1.8mm diameters), and locking screws (14mm to 28mm lengths). Features include cupped plate head, compression slots, and threaded locking screw holes. Mechanical fixation principle.

Indications for Use

Indicated for fixation of unstable radius fractures in patients where closed reduction is not suitable.

Regulatory Classification

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.

Predicate Devices

• LOCON-T® Distal Radial Plating System

Submission Summary (Full Text)

{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 .

page 1 of 2

### 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.

page 2 of 2

{2}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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
Page 1 of *1*