SEARCH EVOLUTION TOTAL KNEE SYSTEM

K021313 · Aesculap, Inc. · JWH · Jul 22, 2002 · Orthopedic

Device Facts

• Record ID: K021313
• Device Name: SEARCH EVOLUTION TOTAL KNEE SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. For Posterior Stabilized (PS) Components: Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The Search Evolution Knee is designed for use with bone cement.

Device Story

Search Evolution Total Knee System; semi-constrained cemented knee prosthesis. System includes femoral components (Posterior Stabilizing or Ligament Cruciate designs) and interchangeable tibial plateaus. Used by orthopedic surgeons in clinical settings for total knee arthroplasty. Device replaces diseased joint surfaces to alleviate pain, correct deformity, and restore function. Femoral components and tibial trays manufactured from CoCrMo; tibial gliding surfaces and patellas from UHMWPE. Designed for fixation with bone cement. Clinical benefit derived from mechanical restoration of joint articulation.

Clinical Evidence

Bench testing only. Biomechanical testing performed in accordance with FDA Draft Guidance for Cemented, Semi-constrained Total Knee Prostheses. No clinical data provided.

Technological Characteristics

Materials: CoCrMo (femoral components, tibial trays), UHMWPE (tibial inserts, patellas). Design: Semi-constrained, cemented, patellofemorotibial prosthesis. Two femoral configurations: Posterior Stabilizing (PS) and Ligament Cruciate (LC).

Indications for Use

Indicated for patients with diseased knee joints due to osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis; patients requiring revision of failed arthroplasties or osteotomies; patients with correctable valgus or varus deformity and moderate flexion contracture. Posterior Stabilized (PS) components indicated for patients with absent/non-functioning posterior cruciate ligament and severe anteroposterior knee instability.

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

• Scorpio Posteriorly Stabilized Knee System (K962152)
• Scorpio Total Stabilizer Total Knee System (K994128)
• Scorpio Posterior Cruciate Retaining Knee System (K974556)
• Gem Knee System (K994214)
• Gem Posterior Stabilized Total Knee System (K010101)

Submission Summary (Full Text)

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# K021313

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS In Accordance with SMDA of 1990

#### Search Evolution Total Knee System

April 1, 2001

| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
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| CONTACT: | Joyce Kilroy<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Search Evolution |
| COMMON NAME: | Search Evolution Total Knee System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 87 JWH |
| CLASSIFICATION: | 888.3560 - Prosthesis, Knee, Patellofemortibial Semi-constrained<br>Cemented, polymer/metal/polymer |
| REVIEW PANEL: | Orthopedics |

#### INDICATIONS FOR USE

The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

For Posterior Stabilized (PS) Components:

Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The Search Evolution Knee is designed for use with bone cement.

#### DEVICE DESCRIPTION

The cemented Search Evolution Knee System is available with two femoral designs, the Posterior Stabilizing (PC) and the Ligament, Cruciate (LC) which retains the ligament (PCL) during implantation. Both designs of the femoral components, and interchangeable tibial plateaus (trays) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.

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510(K) Premarket Notification

Search Evolution Total Knee System

## KO21313

PAGE Z OF Z

### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market.

#### SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Search Evolution Total Knee System is substantially equivalent to:

- . Scorpio Posteriorly Stabilized Knee System (K962152)
- Scorpio Total Stabilizer Total Knee System (K994128) .
- . Scorpio Posterior Cruciate Retaining Knee System (K974556)
- Gem Knee System (K994214) .
- Gem Posterior Stabilized Total Knee System (K010101) .

Attachme]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 2 2002

Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K021313

Trade/Device Name: Search Evolution Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 23, 2002 Received: April 25, 2002

Dear Ms. Kilroy:

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.

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Page 2 - Ms. Joyce Kilroy

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT B.

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Search Evolution Total Knee System Device Name:

Indication for Use:

The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

For Posterior Stabilized (PS) components:

Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The Search Evolution Knee is designed to for use with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (OD Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K021313

| Prescription Use | ______________________________________________________________________________________________________________________________________________________________________________ | or Over-the-Counter Use | ______________________________________________________________________________________________________________________________________________________________________________ |
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(per 21 CFR 801.109)