UNIVATION

K131167 · Aesculap Implant Systems, LLC · HRY · Oct 17, 2013 · Orthopedic

Device Facts

• Record ID: K131167
• Device Name: UNIVATION
• Applicant: Aesculap Implant Systems, LLC
• Product Code: HRY · Orthopedic
• Decision Date: Oct 17, 2013
• 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; consists of femoral, tibial, and meniscal components. Used in orthopedic surgery to treat joint damage. Components implanted by surgeons; femoral and tibial parts made of CoCrMo; meniscal parts made of UHMWPE. Available with PMMA or ZrN coating. Design modifications include posterior fin and distal teeth on femoral and tibial components. Device provides mechanical replacement of damaged joint surfaces to alleviate pain and restore function.

Clinical Evidence

Bench testing only. Endurance testing performed on modified femur and tibial components for 5 million and 10 million load cycles respectively, per ISO 14879-1:2000 and ASTM F1800-07. Results demonstrated performance similar to the predicate device.

Technological Characteristics

Materials: CoCrMo (femoral/tibial), UHMWPE (meniscal). Coatings: PMMA or ZrN. Design: Unicompartmental knee system with posterior fin and distal teeth modifications. Standards: ISO 14879-1:2000, ASTM F1800-07. Sterile, single-use.

Indications for Use

Indicated for patients undergoing surgery for severely painful and/or disabled knee joints due to osteoarthritis, traumatic arthritis, or failed previous implants, where only the medial condyle is affected. 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

• UNIVATION® Unicompartmental Knee System (K081293)

Submission Summary (Full Text)

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| K131167 | Page 1 of 2 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| B. | 510(k) SUMMARY (as required by 21 CFR 807.92) |
| | UNIVATION® Unicompartmental Knee System<br>October 08, 2013 |
| COMPANY: | Aesculap Implant Systems® LLC<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
| CONTACT: | Julie Tom Wing<br>610-984-9147 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | UNIVATION® |
| COMMON NAME: | Unicompartmental Knee System |
| CLASSIFICATION NAME: | Prosthesis, Knee, Femorotibial, Semi-constrained,<br>Cemented, Metal/Polymer |
| REGULATION NUMBER: | 888.3530 |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | HRY |
| PANEL: | Orthopedic |

## SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems®, LLC. UNIVATION® Unicompartmental Knee System is substantially equivalent to the original UNIVATION® Unicompartmental Knee System cleared in 510(K) K081293. The indications for use are equivalent to the predicate.

## 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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## K131167

## INDICATIONS FOR USE

The indications for use remain unchanged as follows:

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 entire UNIVATION® Unicompartmental Knee System was cleared under 510(K) K081293. The fundamental scientific technology and materials for UNIVATION® Unicompartmental Knee System remain the same. The indications for use are equivalent to the predicate.

The only differences are a design modification of the femur and tibia at posterior fin and distal teeth.

## PERFORMANCE DATA

Aesculap conducted a risk analysis of the design modifications and as a result of the risk assessment, customized endurance testing based upon ISO 14879-1:2000 and ASTM F1800-07 were used to evaluate bone interface geometry of both modified femur and tibia components for 5 million load cycles and 10 million load cycles, respectively, The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow, resembling a human figure or a symbol of health and well-being.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 17, 2013

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

Aesculan Implant Systems, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K131167

Trade/Device Name: UNIVATION* Unicompartmental Knec System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: September 18, 2013 Received: September 20, 2013

Dear Ms. Tom Wing:

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 accordunce 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 fabeling must be truthful and not misleading.

If your device is classified (see above) into cither 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 - Ms. Julie Tom Wing

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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UNIVATION Unicompartmental Knee System

Page 1 of 1

#### INDICATIONS FOR USE STATEMENT A.

510(k) Number:_K131167

# 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)

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