GMK SPHERE

K121416 · Medacta International · JWH · Jul 20, 2012 · Orthopedic

Device Facts

• Record ID: K121416
• Device Name: GMK SPHERE
• Applicant: Medacta International
• Product Code: JWH · Orthopedic
• Decision Date: Jul 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

GMK Sphere is a total knee prosthesis system enabling medial-pivot knee joint rotation. Components include Co-Cr-Mo femoral and tibial tray parts and UHMWPE/Ti6Al4V tibial inserts. Used in total knee arthroplasty for patients with severe joint pain or disability. Implanted by orthopedic surgeons in clinical/OR settings. System design aims to restore joint function and stability. Performance verified through mechanical testing of constraint, contact pressure, and range of motion.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included instability analysis, constraint measurements, contact pressure/area, dynamic physiological loads, modular connection, and range of motion per ASTM 2083.

Technological Characteristics

Materials: Co-Cr-Mo (ISO 5832-4), UHMWPE (ISO 5834-2), Ti6Al4V (ISO 5232-3). Design: Medial-pivot total knee prosthesis. Components: Femoral, tibial tray, tibial insert, patella, extension stems. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

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

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

• GMK Total Knee System (K090988)
• Advance Knee System (K972626)
• Advance UC Tibial Insert (K972770)
• Advance Total Knee System (K974328)
• FS 1000 Knee System (K991052)
• Evolis Total Knee System (K081023)
• GMK Total Knee System- Revision (K102437)
• GMK Revision SC Liners (K103170)
• GMK Resurfacing Patella Size 4 (K113571)

Submission Summary (Full Text)

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K121416-113

JUL 30 2012

Image /page/0/Picture/2 description: The image shows the logo for Medacta International. The logo consists of two black triangles, the word "Medacta" in black, and the word "International" in black. There is a plus sign to the right of the word "International".

# 510(k) Summary

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

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

Date Prepared: 05/11/2012

#### DEVICE INFORMATION

Trade/Proprietary Name: GMK Sphere 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

GMK Sphere 510(k)

Section 5 - Page 2 of 4

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# Predicate Devices:

| 510(k) | Product | 510(k) Holder |
|---------|---------------------------------|------------------------------|
| K090988 | GMK Total Knee System | Medacta International |
| K972626 | Advance Knee System | Wright Medical Technology |
| K972770 | Advance UC Tibial Insert | Wright Medical Technology |
| K974328 | Advance Total Knee System | Wright Medical Technology |
| K991052 | FS 1000 Knee System | Renaissance Instruments, LLC |
| K081023 | Evolis Total Knee System | Medacta International |
| K102437 | GMK Total Knee System- Revision | Medacta International |
| K103170 | GMK Revision SC Liners | Medacta International |
| K113571 | GMK Resurfacing Patella Size 4 | Medacta International |

# Product Description

The GMK Sphere Total Knee System allows for medial-pivot rotation of the knee joint and is comprised of the following components:

- Femoral Component Left and Right, Sizes 1-7 � Co-Cr-Mo (ISO 5832-4)
- Tibial tray fixed cemented Left and Right, 4 intermediate sizes . Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex and Congruent, Left and Right, Sizes 1-6, 10mm-20mm . UHMWPE (ISO 5834 -2) Type 1, Ti6Al4V (ISO 5232-3)

The following components of the GMK Sphere have been previously cleared:

- Resurfacing patella Sizes 1-4 (K090988 and K113571) .
- Tibial tray fixed cemented Left and Right, Sizes 1-6 (K090988) .
- Primary extension stem Ø11mm / L 65 mm (K090988) .

#### Indications for Use

The GMK knee prosthesis 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.

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

GMK Sphere 510(k)

Section 5 - Page 3 of 4

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K121416 (³/₃)

#### Comparison to Predicate Devices

The indications for use of the GMK Sphere are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the GMK Sphere are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

### Performance Testing

The GMK Sphere was tested for the following compared to the predicate devices:

- Instability due to design and surface area .
- Constraint measurements .
- Contact pressures and areas .
- Dynamic physiological loads .
- Modular connection .
- Range of Motion ASTM 2083 .

A review of the mechanical data indicates that the GMK Sphere is equivalent to devices . currently cleared for use and is capable of withstanding expected in vivo foading without failure.

#### Conclusion:

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

Section 5 - Page 4 of 4

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

JUL 30 2012

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

Re: K121416

Trade/Device Name: GMK Sphere Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: Class II Product Code: JWH Dated: May 11, 2012 Received: May 11, 2012

### Dear Mr. Gross

We have reviewed your Section 510(k) premarket notification of intent to market the device w & now and have 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 I ou may, dicrore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviteration. 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.

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#### Page 2 - Mr. Adam Gross

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.

Mark N. Malkerson

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

Enclosure

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# Indications for Use

510(k) Number (if known): K | 2 | 4 | 0

Device Name: GMK Sphere

Indications for Use.

The GMK knee prosthesis 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.

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

A

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 121416

Prescription Use X (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)

GMK Sphere 510(k) May 10, 2012

Section 4 - Page 2 of 2

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