G7 Dual Mobility System, Active Articulation System

K161190 · Biomet, Inc. · LPH · May 26, 2016 · Orthopedic

Device Facts

• Record ID: K161190
• Device Name: G7 Dual Mobility System, Active Articulation System
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 26, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision of previously failed total hip arthroplasty. 6. Dislocation risks. The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended applications.

Device Story

Dual articulation hip prosthesis system; features two articulating surfaces in single joint space. UHMWPE bearing assembles over femoral head; femoral head articulates on inner concave surface of bearing; assembly articulates within metal liner or acetabular shell. Used in primary and revision hip arthroplasty. System expands compatibility to include specific Zimmer cobalt chrome and ceramic femoral heads and stem combinations. Intended for uncemented applications. Single-use implants. Operated by orthopedic surgeons in clinical/surgical settings. Provides stable joint articulation; reduces dislocation risk; restores hip function.

Clinical Evidence

Bench testing only. No clinical or animal testing required. Performance data includes wear justification reports (ISO 7206-2:2011), interference fit analyses, push-in/pull-out/lever-out analysis (ASTM F1820-13), and range of motion analyses (ISO 21535:2007).

Technological Characteristics

Materials: UHMWPE, cobalt chrome, ceramic. Design: Dual articulation hip prosthesis, uncemented. Standards: ISO 7206-2:2011 (wear), ASTM F1820-13 (push-in/pull-out/lever-out), ISO 21535:2007 (range of motion). Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric), revision of failed total hip arthroplasty, and patients at risk of dislocation.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• G7 Dual Mobility System (K150522)
• E1 Avantage Heads (K101336)
• ArComXL Active Articulation Heads (K110555)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.

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

May 26, 2016

Biomet, Incorporated Ms. Emilv Manuel Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581-0587

Re: K161190 Trade/Device Name: G7 Dual Mobility System, Active Articulation System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, OQG, KWY, LZO Dated: April 25, 2016 Received: April 27, 2016

Dear Mr. Manuel:

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 Parts 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K161190

Device Name G7 Dual Mobility System Active Articulation System

Indications for Use (Describe)

1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

5. Revision of previously failed total hip arthroplasty.

6. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended applications.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white. The overall impression is clean and modern.

# 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the expanded compatibility of the G7 Dual Mobility System and Active Articulation System 510(k) premarket notification.

| Sponsor: | Biomet Inc.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Emily Manuel<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| Date: | April 25, 2016 |
| Subject Device: | Trade Name: G7 Dual Mobility System<br>Active Articulation System<br>Common Name: Hip Prosthesis<br>Product Code(s): LPH, OQG, KWY, LZO<br>Regulation/Description:<br>• 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented prosthesis<br>• 21 CFR 888.3390 – Prosthesis, Hip, Hemi-, Femoral,<br>Metal/Polymer, Cemented or Uncemented<br>• 21 CFR 888.3353 - Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented |

## Legally marketed devices to which substantial equivalence is claimed:

- G7 Dual Mobility System (K150522)
- E1 Avantage Heads (K101336)
- ArComXL Active Articulation Heads (K110555)

## Device Description

The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include an Active Articulation polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white. The overall impression is clean and modern.

The Zimmer cobalt chrome and ceramic femoral heads are proposed as compatible femoral head components. As part of this additional compatibility, legally marketed Zimmer stem combinations will be included for system compatibility.

## Intended Use and Indications for Use

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular
- Rheumatoid arthritis. 2.
- 3. Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4. proximal femur with head involvement, unmanageable by other techniques.
- 5. Revision of previously failed total hip arthroplasty.
- 6. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

#### Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended Use: The intended use of the proposed compatibility of the G7 Dual Mobility . and Active Articulation Systems is identical to the intended use of the predicates. The intended use of the predicates is not impacted by the proposed expanded compatibility.
- Indications for Use: The indications for use of the proposed compatibility of the G7 Dual ● Mobility and Active Articulation Systems is identical to the indications for use of the predicates. The indications for use of the predicates is not impacted by the proposed expanded compatibility.
- . Materials: The materials of the proposed compatible components of the G7 Dual Mobility and Active Articulation Systems are identical to the materials of the predicates. The materials of the predicates are not impacted by the proposed expanded compatibility.
- . Design Features: The design features of the proposed compatible components of the G7 Dual Mobility and Active Articulation Systems are identical to the design features of the predicates. There have been no design changes to the originally cleared predicate devices as a result of the proposed expanded compatibility.
- Sterilization: Sterilizaiton methods and processes of the proposed compatible ● components of the G7 Dual Mobility and Active Articulation Systems is identical to the sterilization methods and processes of the predicates. Sterilization methods and processes are not impacted by the proposed expanded compatibility. Subject and predicate devices are provided sterile, single-use only.

#### Summary of Performance Data

Results from performance tests and engineering analyses demonstrate the subject G7 Dual Mobility and Active Articulation Systems, including proposed new compatible components, remain substantially equivalent to the systems cleared in K150522, K101336 and K110555. No

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "BIOMET" in a sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white.

animal or clinical testing was required to support substantial equivalence. A description of the tests performed on the proposed compatibility is as follows:

- Wear Justification Reports ISO 7206-2: 2011 ●
- Interference Fit Analyses
- Push-in, Pull-out, Lever-out Analysis - ASTM F1820-13
- Range of Motion Analyses – ISO 21535:2007

## Substantial Equivalence Conclusion

The proposed G7 Dual Mobility System and Active Articulation System have the same intended use and indications for use as the predicates. Performance test data and analyses demonstrate the proposed expanded compatibility is as safe and effective and is substantially equivalent to the legally marketed predicates.