UNIVATION UNICONDYLAR KNEE SYSTEM

K081293 · Aesculap Implant Systems, Inc. · HRY · Sep 22, 2008 · Orthopedic

Device Facts

• Record ID: K081293
• Device Name: UNIVATION UNICONDYLAR KNEE SYSTEM
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Sep 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

Device Story

Unicompartmental knee prosthesis replacing one knee condyle (medial). System includes femoral, tibial, and meniscal components in various sizes. Femoral/tibial components made of CoCrMo; meniscal components made of UHMWPE. Optional PMMA or ZrN coating. Used in orthopedic surgery to address joint damage; implanted by surgeons. Provides mechanical replacement of damaged joint surfaces to reduce pain and restore function.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance for orthopedic devices, including cemented, semi-constrained total knee prostheses and PMMA bone cement requirements.

Technological Characteristics

Materials: CoCrMo (femoral/tibial), UHMWPE (meniscal). Coatings: PMMA or ZrN. Design: Semi-constrained, cemented, metal/polymer unicompartmental knee prosthesis. Single-use, sterile.

Indications for Use

Indicated for patients with severe pain or disability due to osteoarthritis, traumatic arthritis, or failed previous implant, requiring medial unicompartmental knee replacement. For cemented use only.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Millar/Galante Precoated Unicompartmental Knee (K880155/K942263/K010685)
• Columbus Total Knee System MIOS CR/PS Tibial Tray (K071499)
• Columbus Total Knee System AS (K071220)

Submission Summary (Full Text)

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SEP 2 2 2008

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## UNIVATION® Unicompartmental Knee System May 6, 2008

| COMPANY: | Aesculap Implant Systems ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle<br>610-984-9274 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | UNIVATION® |
| COMMON NAME: | Unicompartmental Knee System |
| CLASSIFICATION NAME: | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented,<br>Metal/Polymer |
| REGULATION NUMBER: | 888.3530 |
| PRODUCT CODE: | HRY |

#### SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems®, Inc. believes that the UNIVATION® Unicompartmental Knee System is substantially equivalent to:

- Millar/Galante Precoated Unicompartmental Knee (K880155/K942263/K010685) .
- Columbus Total Knee System MIOS CR/PS Tibial Tray (K071499)
- Columbus Total Knee System AS (K071220) .

# DEVICE DESCRIPTION

The Univation® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The Univation® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (zirconium nitride) coating. All components are sterile and for single use only.

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## INDICATIONS FOR USE

The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis. traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The components of the Aesculap Implant Systems® Unicompartmental Knee System are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.

#### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the

- . "Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses",
- "Guidance Document for Polymethylmethacrylate (PMMA) Bone Cement', and .
- . "Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

SEP 2 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K081293

Trade/Device Name: UNIVATION® Unicompartmental Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: August 7, 2008 Received: August 8, 2008

Dear Ms. Boyle:

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 (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 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. Lisa M. Boyle

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millman

- Mark N. Melkerson 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 A.

510(k) Number:_K081293

## Device Name: UNIVATION® Unicompartmental Knee System

#### Indications for Use:

The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millhouse

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Neurological Dev

K081293

510(k) Number