EVOLUTION MP TOTAL KNEE SYSTEM

K102380 · Wrightmedicaltechnologyinc · JWH · Jan 7, 2011 · Orthopedic

Device Facts

• Record ID: K102380
• Device Name: EVOLUTION MP TOTAL KNEE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JWH · Orthopedic
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; 2) correction of functional deformity; 3) 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION™ Total Knee System is for cemented use only.

Device Story

EVOLUTION™ MP Total Knee System is a semi-constrained cemented knee prosthesis; intended for knee arthroplasty. Modification increases functional range of motion; no new components introduced. Device consists of existing metal/polymer implants. Evaluated via mechanical testing and engineering analyses, including static stability and contact area testing. Used by orthopedic surgeons in clinical settings to replace damaged knee joints; restores joint function; corrects deformities; manages fractures. Benefits patients through improved mobility and pain relief.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via mechanical testing and engineering analyses, including static stability and contact area testing, to confirm equivalence to predicate devices.

Technological Characteristics

Semi-constrained cemented knee prosthesis. Materials: Metal/Polymer. Components: Patellofemorotibial. Regulatory Class II. Device is a mechanical implant system; no software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing knee arthroplasty for noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity correction, revision procedures, or unmanageable fractures. Cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• EVOLUTION™ MP Total Knee System (K093552)
• ADVANCE® Total Knee System (K063731)
• ADVANCE® Total Knee System (K033890)
• ADVANCE® Total Knee System (K973524)
• ADVANCE® Total Knee System (K972626)
• ADVANCE® Total Knee System (K960617)
• AXIOM® Total Knee System (K894334)

Submission Summary (Full Text)

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K102380

JAN 7 2011

### 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, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION™ Total Knee System.

| Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Rd, Arlington TN, 38002<br>[phone] |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 16, 2010 |
| Contact Person: | Ryan Ross<br>Senior Regulatory Affairs Specialist |
| Proprietary Name: | EVOLUTION™ MP Total Knee System |
| Common Name: | Total Knee System |
| Classification Name and Reference: | 21 CFR 888.3560 Knee joint Patellofemorotibial<br>Polymer/Metal/Polymer Semi-Constrained<br>Cemented Prosthesis Class II |
| Subject Product Code and Panel Code: | 21 CFR 888.3530 Knee joint Femorotibial<br>Metal/Polymer Semi-Constrained Cemented<br>Prosthesis Class II<br>Orthopedics/87/ JWH, HRY |
| Predicate Devices: | EVOLUTION™ MP Total Knee System, K093552<br>ADVANCE® Total Knee System, K063731,<br>K033890, K973524, K972626, K960617<br>AXIOM® Total Knee System, K894334 |

#### DEVICE INFORMATION

A. Intended Use

The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

- 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2)
- correction of functional deformity; 3)
- 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION™ Total Knee System is for cemented use only.

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#### B. Device Description

The subject of this Special 510(k)-Premarket Notification is to request a performance specification modification to increase the functional range of motion for the Wright Medical Technology, Inc. EVOLUTION™ MP Total Knee System. The EVOLUTION™ MP Total Knee System consists of existing total knee implant devices. No new total knee components are being introduced as a result of this Special 510(k) premarket notification.

The EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing. A review of these results indicates that the EVOLUTION™ MP Total Knee System is equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

## C. Substantial Equivalence Information

The indications for use of the EVOLUTION™ MP Total Knee System are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the EVOLUTION™ MP Total Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle. The eagle is facing to the right and has three lines representing its wings.

7 2011

JAN

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. % Mr. Ryan Ross Senior Regulatory Affairs Specialist 5677 Airline Road Arlington Tennessee, 38002

Re: K102380

Trade/Device Name: EVOLUTION™ MP Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY Dated: December 7, 2010 Received: December 8, 2010

Dear Mr. Ross:

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. 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

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Page 2 - Mr. Ryan Ross

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark A. Matheson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): 12 02380

Device Name: EVOLUTION™ MP Total Knee System

Indications For Use:

The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

- 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION™ Total Knee System is for cemented use only.

Prescription Use X (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)

for n. Mellekon

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