VEGA KNEE SYSTEM

K140452 · Aesculap Implant Systems · JWH · Mar 25, 2014 · Orthopedic

Device Facts

• Record ID: K140452
• Device Name: VEGA KNEE SYSTEM
• Applicant: Aesculap Implant Systems
• Product Code: JWH · Orthopedic
• Decision Date: Mar 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VEGA 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. Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee ioint. The VEGA Knee System is designed for use with bone cement.

Device Story

VEGA Knee System is a semi-constrained, cemented total knee prosthesis; used for joint reconstruction. Components include femoral component, tibial plateau, extension stem (CoCrMo with Zirconium nitride coating), tibial inserts/patella (UHMWPE), and tibial plug (PEEK). System allows optional use of compatible Columbus CRA/PSA tibial plateaus and augments. Device implanted by orthopedic surgeons in clinical/hospital settings. Provides mechanical stability and joint function for patients with degenerative or post-traumatic knee conditions. System is sterile, single-use.

Clinical Evidence

Bench testing only. Geometrical worse-case comparison analysis performed to evaluate cross-compatibility between Aesculap Columbus CRA/PSA tibial plateau and VEGA Knee System gliding surfaces. Results demonstrated acceptable criteria and no new risks.

Technological Characteristics

Semi-constrained cemented prosthesis. Materials: CoCrMo with Zirconium nitride (ZrN) coating (femoral/tibial/stem), UHMWPE (inserts/patella), PEEK (tibial plug). Modular components in various sizes. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring knee joint reconstruction due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or revision of failed arthroplasties/osteotomies with persistent pain, deformity, or dysfunction. Also indicated for correctable valgus/varus deformity and moderate flexion contracture. PS components indicated for 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

• VEGA Knee System (K101281)
• VEGA Knee System (K121879)

Reference Devices

• Columbus CRA/PSA tibial plateaus and augments (K053390)
• Columbus CRA/PSA tibial plateaus and augments (K071220)
• Columbus CRA/PSA tibial plateaus and augments (K120955)

Submission Summary (Full Text)

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### K140452

Page 1 of 2

#### B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# VEGA Knee System February 20, 2014

| COMPANY: | Aesculap® Implant Systems, LLC<br>3773 Corporate Parkway<br>Center Valley, PA 18034 | |
|----------------------|-------------------------------------------------------------------------------------|--|
| ESTABLISHMENT | | |
| REGISTRATION NUMBER: | 3005673311 | |

| CONTACT: | Julie Tom Wing |
|----------|----------------------------|
| | 610-984-9147 (phone) |
| | 610-791-6882 (fax) |
| | [e-mail] |

### DEVICE

| TRADE NAME: | VEGA Knee System |
|----------------------|----------------------------------------------------------------------------------------------|
| COMMON NAME: | Total Knee System |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | JWH |
| REGULATION NUMBER: | 888.3560 |
| CLASSIFICATION NAME: | Knee Joint Patellofemorotibial Polymer/Metal/Polymer<br>Semi constrained Cemented Prosthesis |

# SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the optional use of compatible Columbus CRA/PSA tibial plateaus and augments (K053390; K071220 and K120955) are a line extension to Aesculap's VEGA Knee System (K101281 and K121879). This line extension remains substantially equivalent to the currently marketed Aesculap Implant Systems VEGA Knee System.

# DEVICE DESCRIPTION

The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug is made of PEEK. The system is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateau and augments (CRA/PSA). All components are sterile and for single use only.

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K140452 Page 2 of 2

# INDICATIONS FOR USE

The VEGA 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.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee ioint.

The VEGA Knee System is designed for use with bone cement.

### TECHNOLOGICAL CHARACTERISTICS (Compared to the Predicate)

The VEGA Knee System was cleared under K101281 and K121879. The fundamental scientific technology and materials for the VEGA system remain the same. The only difference is the addition of optional compatible Aesculap Columbus cruciate retaining/posterior stabilizing (CRA/PSA) tibial plateau and wedges previously cleared in 510(K) K053390, K071220 and K120955.

### PERFORMANCE DATA

As a result of the risk analysis, a geometrical worse case comparison was used to determine cross compatibility of Aesculap Columbus CRA/PSA tibial plateau with Aesculap's VEGA Knee System gliding surfaces. Results of the geometrical analysis demonstrated acceptable criteria and showed that there are no new risks associated with the optional use Columbus CRA/PSA .

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

March 25, 2014

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

Re: K140452 Trade/Device Name: Vega Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH Dated: February 21, 2014 Received: February 24, 2014

Dear Ms. Julie 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 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 that + D7 I has hatutes 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Julie Tom Wing

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 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wigqins

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

Enclosure

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#### K140452

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) K140452

Device Name VEGA Knee System

#### Indications for Use (Describe)

The VEGA Knee System is indicated for use in reconstruction of the joint caused by ostearthrilis, theumatoid arthris, post-traumatic arthritis, the need to revise failed arthroplastics where pain, deformity or dysfunction persist and for paticats suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-finctioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee System is designed for use with bone coment.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey L. Hanley, Ph.D

Division of Orthopedic Devices

| FORM FDA 3881 (1/14) | Page 1 of 2 |
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