CONSENSUS REVISION KNEE SYSTEM

K100542 · Consensus Orthopedics, Inc. · JWH · Jun 24, 2010 · Orthopedic

Device Facts

• Record ID: K100542
• Device Name: CONSENSUS REVISION KNEE SYSTEM
• Applicant: Consensus Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condvie. B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy) C. Failed osteotomy or unicompartmental replacements. D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery F. Moderate valgus, varus, or flexion deformities G. All CONSENSUS® RKS femoral components and tibial baseplates are intended FOR CEMENTED USE ONLY. H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.

Device Story

Consensus® Revision Knee System (RKS) is a semi-constrained cemented knee prosthesis; used for total knee arthroplasty in patients with severe joint degeneration or failed prior interventions. System components include femoral components, tibial baseplates, and stems. Femoral components and tibial baseplates are indicated for cemented fixation; stems are indicated for press-fit non-cemented fixation. Device implanted by orthopedic surgeons in an operating room setting. Provides mechanical stabilization and restoration of joint function for patients with significant bone loss or deformity. Clinical benefit derived from replacing damaged joint surfaces and stabilizing the knee joint to improve mobility and reduce pain.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Semi-constrained cemented knee prosthesis. Materials include metal and polymer components. Femoral/tibial components: cemented fixation. Stems: press-fit non-cemented fixation. Regulation: 21 CFR 888.3560. Product code: JWH.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, post-traumatic joint loss, failed prior surgeries (osteotomy, unicompartmental, or failed total knee), or moderate valgus/varus/flexion deformities. Requires sufficient bone stock.

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).

Submission Summary (Full Text)

{0}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

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

## JUN 2 4 2010

Consensus Orthopedics, Inc. % Mr. Matt Hull Director, QS & RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

Re: K100542

Trade/Device Name: Consensus® Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 14, 2010 Received: June 14, 2010

Dear Mr. Hull:

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

{1}------------------------------------------------

#### Page 2 - Mr. Matt Hull

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K100542

Device Name: Consensus® Revision Knee System

Indications For Use:

- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condvie.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
- G. All CONSENSUS® RKS femoral components and tibial baseplates are intended FOR CEMENTED USE ONLY.
- H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF, NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sautu for mxm
(Division Sign Off)

(Dission Sign-Of Division of Surgical, Orthopedic. and Restorative Devices

Page 1 of 1

510(k) Number K100542