GMK EXTENSION

K142069 · Medacta International · JWH · Dec 2, 2014 · Orthopedic

Device Facts

• Record ID: K142069
• Device Name: GMK EXTENSION
• Applicant: Medacta International
• Product Code: JWH · Orthopedic
• Decision Date: Dec 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis. · Avascular necrosis of femoral condyle. · Post traumatic loss of joint configuration. · Primary implantation failure. Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

Device Story

GMK Total Knee System is a line extension of orthopedic implants for total knee arthroplasty; components include femoral implants (STD and PS versions) in various sizes. Device is intended for cemented fixation; requires sufficient sound bone for seating. System includes optional tibial wedges and screwed tibial augments; specific configurations (semi-constrained liners or revision trays) mandate use of extension stems. Implants are used by orthopedic surgeons in clinical/OR settings to restore joint function and alleviate pain in patients with degenerative or traumatic joint disease. Output is a reconstructed knee joint; clinical decision-making relies on surgeon assessment of bone quality and joint stability. Benefits include pain relief and restoration of joint configuration.

Clinical Evidence

Bench testing only. Performance evaluated via risk analysis and design verification protocols comparing mechanical strength, range of motion, constraint, and wear characteristics against worst-case predicate devices.

Technological Characteristics

Materials: Co-Cr-Mo (ISO 5832-4). Design: Cemented patellofemorotibial polymer/metal/polymer semi-constrained prosthesis. Components include femoral implants, tibial wedges, and screwed tibial augments. Connectivity: N/A (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for patients with severely painful/disabled joints due to arthritis (osteo, traumatic, rheumatoid, polyarthritis), avascular necrosis of femoral condyle, post-traumatic joint loss, or primary implantation failure requiring total knee arthroplasty with sufficient bone stock for component support.

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

• Evolis Total Knee System (K081023)
• GMK Total Knee System (K090988)
• GMK Femur Size 7 (K120790)
• GMK Sphere (K121416)
• GMK Narrow (K122232)
• GMK Sphere Extension (K140826)

Submission Summary (Full Text)

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December 2, 2014

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

Medacta International Mr. Adam Gross Director of Regulatory, Quality and Compliance 1556 West Carroll Avenue Chicago, Illinois 60607

Re: K142069

Trade/Device Name: GMK Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 1, 2014 Received: October 2, 2014

Dear Mr. Gross:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free 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" (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.

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

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K142069

#### Device Name GMK Total Knee System

#### Indications for Use (Describe)

The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.

· Avascular necrosis of femoral condyle.

· Post traumatic loss of joint configuration.

· Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The screwed tibial augments are for screwed fixation to the tibial baseplate.

In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

In case a GMK Revision tibial tray is used, an extension stem must be implanted.

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)

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# 510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

- Contact Person: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: [phone] Fax: [phone] Email: [e-mail]
July 30, 2014 Date Prepared:

## DEVICE INFORMATION

Trade/Proprietary Name: GMK Total Knee System Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. 21 CFR 888.3560 Class II Product Code(s): JWH

Predicate Device(s):

| 510(k) | Product | 510(k) Holder | Clearance<br>Date |
|---------|--------------------------|-----------------------|-------------------|
| K081023 | Evolis Total Knee System | Medacta International | 10/22/2008 |
| K090988 | GMK Total Knee System | Medacta International | 7/10/2009 |
| K120790 | GMK Femur Size 7 | Medacta International | 6/8/2012 |
| K121416 | GMK Sphere | Medacta International | 7/30/2012 |
| K122232 | GMK Narrow | Medacta International | 9/28/2012 |
| K140826 | GMK Sphere Extension | Medacta International | 7/15/2014 |

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## Product Description

The GMK Extension is a line extension to the Medacta GMK Total Knee System and consists of the following components which are all made from Co-Cr-Mo (ISO 5832-4):

- . Femur STD cemented #0, Left and Right
- . Femur PS cemented #0, Left and Right
- Femur STD cemented #1 and #7 Narrow, Left and Right .
- . Femur PS cemented #1 and #7 Narrow, Left and Right

# Indications for Use

The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.

- · Avascular necrosis of femoral condyle.
- Post traumatic loss of joint configuration.
- · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cvlinders and bone cement.

The screwed tibial augments are for screwed fixation to the tibial baseplate.

In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

In case a GMK Revision tibial tray is used, an extension stem must be implanted.

### Comparison to Predicate Devices

The indications for use, design features and materials of the GMK Extension are substantially equivalent to those of the predicate devices. The substantial equivalence of the GMK Extension implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.

### Performance Testing

The modification to the device system to include the addition of the GMK Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA quidance, and comparison to the predicate device svstem. The GMK Extension was compared to the worst case predicate device in terms of mechanical strength, range of motion, constraints to prevent risk of dislocation, and

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contact pressures/wear and it was determined that the GMK Extension is not worst case.

## Conclusion:

Based on the above information, the GMK Extension can be considered as substantially equivalent to its predicate devices.