SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)

K032108 · Aesculap, Inc. · MBH · Jan 15, 2004 · Orthopedic

Device Facts

• Record ID: K032108
• Device Name: SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
• Applicant: Aesculap, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgerv. The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement. The Search Evolution porous coated femoral component is designed for use without bone cement

Device Story

Total knee replacement system; includes femoral components and tibial tray. Femoral components available in porous-coated (uncemented) or non-porous (cemented) versions. Porous coating uses plasma-sprayed titanium. Designed to retain posterior cruciate ligament (LC). Used by orthopedic surgeons in clinical settings to relieve pain and restore joint function. Benefits include improved mobility and pain reduction for patients with degenerative or traumatic knee conditions.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance for cemented, semi-constrained total knee prostheses and guidance for orthopedic implants with modified metallic surfaces apposing bone or bone cement.

Technological Characteristics

Femoral components manufactured from CoCrMo alloy. Porous coating consists of titanium (Ti) applied via plasma spray technique conforming to ISO 5832. System includes both cemented and uncemented (porous-coated) options. Designed for posterior cruciate ligament (LC) retention.

Indications for Use

Indicated for patients requiring knee joint replacement due to osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities, or revision surgery.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Columbus (CR) Total Knee System (K022672)
• Search Evolution Total Knee System (K021313)
• Scorpio Posterior Cruciate Retaining Knee System (K974556)
• Gem Knee System (K994214)

Submission Summary (Full Text)

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JAN 1 5 2004

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

### SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM

July 7, 2003

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>joyce.kilroy @ aesculap.com (email) |
| TRADE NAME: | Search Evolution (LC) Total Knee System (Porous Coated) |
| COMMON NAME: | Porous Coated Femoral Component |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | MBH |
| CLASSIFICATION: | 888.3565 |
| REVIEW PANEL: | Orthopedics |

#### INTENDED USE

The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgerv.

The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.

The Search Evolution porous coated femoral component is designed for use without bone cement

#### DEVICE DESCRIPTION

The Search Evolution (LC) Total Knee System is available with two femoral designs. Each retains the PCL, ligament cruciate (LC) during implantation and both femoral components are manufactured from CoCrMo. One is non-porous coated and is intended to be used with bone cement. The other is porous coated and intended to be used without bone cement. The coating is Ti, which conforms to ISO 5832 and is applied using the plasma spray technique.

#### 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 done where applicable. In addition, testing per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" were completed.

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#### SUBSTANTIAL EQUIVALENCE

Aesculap believes that the new porous coated femoral component of the Search Evolution Total Knee System is substantially equivalent in design to:

- Columbus (CR) Total Knee System (K022672) .
- Search Evolution Total Knee System (K021313) .
- Scorpio Posterior Cruciate Retaining Knee System (K974556) .
- Gem Knee System (K994214) .

Substantial equivalence to the intended use of uncemented fixation for the porous coated femoral component is established by:

- 21 CFR 888.3565; Product Code: MBH .
- Guidance document: "Class II Special Controls Guidance Document: Knee Joint . Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coasted Uncemented Prostheses; Guidance for Industry and FDA".

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 1 5 2004

Ms. Joyce Kilroy Director Regulatory Affairs Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034

Re: K032108

K032108
Trade/Device Name: Scarch Evolution (LC) Total Knee System (Porous Coated) Regulation Number: 21 CFR 888.3565 Regulation Number: 21 C.FK 886.3503
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: October 16, 2003 Received: October 17, 2003

Dear Ms. Kilroy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketcol in interstate for use stated in the encrosure) to regally mancted to the Medical Device Amendments, or to commerce prof to May 20, 1770, the enactired in accordance with the Federal Food. Drug, devices that have bect recurse in accordance who a premarket approval application (PMA). and Cosmelle Act (Act) that do not require approvine as a controls provisions of the Act. The You may, therefore, market the device, equirements for annual registration, listing of general controls provisions of the recess, 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 is Classified (see above) the Existing major regulations allecting your device can be may be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the exac ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Dr o lossailer of the complies with other requirements of the Act that I DA has made a necessions administered by other Federal agencies. You must of any it ciclar statutes and regalations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic north in the quality systems (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), please contact the 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 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

Sincercly yours,

Mark N. Mulhern

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

510(k) Number (if known): _ K032108

Search Evolution (LC) Total Knee System (Porous Coated) Device Name:

Indications For Use:

The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.

The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.

The Search Evolution porous coated femoral component is designed for use without bone cement.

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)

for Mark N. Milliken

tiv

Ko32108

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