GMK FULL PE TIBIAL COMPONENTS

K131310 · Medacta International · JWH · Aug 22, 2013 · Orthopedic

Device Facts

• Record ID: K131310
• Device Name: GMK FULL PE TIBIAL COMPONENTS
• Applicant: Medacta International
• Product Code: JWH · Orthopedic
• Decision Date: Aug 22, 2013
• 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 augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.

Device Story

GMK Full PE Tibial Components are symmetric, ultracongruent, or posterior-stabilized knee implants; sizes 1-6; thicknesses 10-17mm; +/- 10° axial rotation. Used in total knee arthroplasty; replaces metal-backed tibial trays. Implanted by orthopedic surgeons in clinical settings. Includes radiopaque wires for radiographic positioning verification. Provides structural joint replacement; restores mobility; reduces pain. Mechanical performance validated via bench testing for breakage, detachment, wear, and range of motion.

Clinical Evidence

Bench testing only. Evaluated for breakage, implant detachment, articulating surface wear, luxation/subluxation, and range of motion per ASTM 2083. Results indicate equivalence to predicate devices and capability to withstand expected in vivo loading.

Technological Characteristics

UHMWPE (ISO 5834-2 Type 1) tibial components; AISI 316 LVM (ISO 5832-1) radiopaque wires. Symmetric design; ultracongruent or posterior-stabilized. Cemented fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to severe pain/disability from arthritis (traumatic, rheumatoid, polyarthritis), avascular necrosis of the femoral condyle, post-traumatic joint configuration loss, or primary implantation failure. Requires sufficient sound bone for component seating.

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

• Genesis II CR (K951987)
• Genesis II PS (K953274)
• GMK Total Knee System (K090988, K113571, K120790, K122232)
• Evolis Total Knee System (K081023)
• NexGen LPS (K991581, K042271)
• Natural Knee (K070214)

Submission Summary (Full Text)

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K131310 (1/3)

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# 510(k) Summary

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

**AUG 2 2 2013**

Contact Person: Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: April 25, 2013

DEVICE INFORMATION

Trade/Proprietary Name: GMK Full PE Tibial Components Common Name: Total Knee Prosthesis Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis

21 CFR 888.3560 Class II Device Product Codes: JWH

| Predicate Devices: | | | |
|---------------------------------------|-----------------------------|------------------------|---------------------------------------------|
| 510(k) | Product | 510(k) Holder | Clearance Date |
| K951987 | Genesis II CR | Smith and Nephew, Inc. | 08/22/1995 |
| K953274 | Genesis II PS | Smith and Nephew, Inc. | 02/05/1996 |
| K090988, K113571,<br>K120790, K122232 | GMK Total Knee<br>System | Medacta International | 7/10/2009,1/27/2012,<br>6/8/2012, 9/28/2012 |
| K081023 | Evolis Total Knee<br>System | Medacta International | 10/22/2008 |
| K991581, K042271 | NexGen LPS | Zimmer | 7/30/1999, 10/13/2004 |
| K070214 | Natural Knee | Zimmer | 3/16/2007 |

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# Product Description

The GMK Full PE Tibial Components are symmetric and come in ultracongruent and posterior-stabilized designs in sizes 1-6 with thicknesses of 10, 12, 14, and 17mm and have an axial rotation of +/- 10°. The GMK Full PE Tibial Components are made from UHMWPE (ISO 5834 -2) Type 1. There are two radiopaque wires made of AISI 316 LVM (ISO 5832-1) to check the final implant position during radiography. The GMK Full PE Tibial Components can be used in place of the metal backed solution (K090988), where a component entirely made of UHMWPE replaces the metal backed solution (metallic tibial tray + UHMWPE tibial insert, K090988).

# 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 confiquration. .
- . Primary implantation failure.

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

If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.

# Comparison to Predicate Devices

The indications for use, design features, and materials of the subject device are substantially equivalent to those of the predicate devices. The design features of both the GMK Full PE Tibial Components and the predicates come in ultracongruent and posterior-stabilized designs in similar sizes and thicknesses. The GMK Full PE Tibial Components and the predicates are both made of UHMWPE (ISO 5834 -2) Type 1 and can be used in place of the metal backed solution (metallic tibial tray + UHMWPE tibial insert).

The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the GMK Full PE Tibial Components are adequately supported by the substantial equivalence information. materials information, and analysis data provided within this Premarket Notification.

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#### Performance Testing

The GMK Full PE Tibial Components was tested for the following compared to the predicate devices:

- Breakage .
- Implant detachment .
- Excessive wear of the articulating surface .
- Femoral luxation or subluxation due to insufficient constraints .
- Insufficient mobility and/or Range of Motion (ROM) according to ASTM 2083 .

A review of the mechanical data indicates that the GMK Full PE Tibial Components is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure.

#### Conclusion:

Based on the above information, the GMK Full PE Tibial Components can be considered as substantially equivalent to its predicate devices.

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

August 22, 2013

Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, California 93012

Re: K131310

Trade/Device Name: GMK Full PE Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 2, 2013 Received: July 3, 2013

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

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#### Page 2 - Mr. Adam Gross

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 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/Resources/or 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

# 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): K131310

Device Name: GMK Full PE Tibial Components

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 augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.

Prescription Use × (21 CFR 801 Subpart D)

AND/OR

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

(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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GMK Full PE Tibial Components 510(k) May 3, 2013

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