VERSAFIT CUP DOUBLE MOBILITY SYSTEM

K083116 · Medacta International S.A. · MEH · Apr 7, 2009 · Orthopedic

Device Facts

• Record ID: K083116
• Device Name: VERSAFIT CUP DOUBLE MOBILITY SYSTEM
• Applicant: Medacta International S.A.
• Product Code: MEH · Orthopedic
• Decision Date: Apr 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Versafit Cup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: - Severely painful and/or disabled joint as a result of osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis, - Congenital hip dysplasia . - Ankylosing spondylitis . - Avascular necrosis of the femoral head . - Acute traumatic fracture of the femoral head or neck . - Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Dislocation risks .

Device Story

Versafit Cup Double Mobility is a two-piece modular acetabular component for total hip arthroplasty; consists of a metal shell and a polyethylene liner. Metal shell is machined from stainless steel M30NW; outer surface features Ti plasma spray or HA/Ti plasma spray coatings. Polyethylene liner is standard UHMWPE, designed to articulate freely within the polished inner surface of the metal cup. Device is intended for cementless fixation. Used in primary or revision hip surgery; implanted by orthopedic surgeons. Compatible with Medacta Quadra S Stems and CoCrMo or MectaCer BIOLOX forte Ceramic ball heads (22mm and 28mm). Provides dual mobility articulation to improve joint stability and reduce dislocation risk.

Clinical Evidence

No clinical data. Performance verified through bench testing conducted in accordance with international standards and FDA guidance documents on worst-case component sizes and designs.

Technological Characteristics

Modular acetabular component; metal shell (stainless steel M30NW, ISO 5832-9) with Ti or HA/Ti plasma spray coatings; UHMWPE liner (ISO 5834). Dual mobility articulation principle. Cementless fixation. Compatible with 22mm/28mm CoCrMo or ceramic ball heads.

Indications for Use

Indicated for skeletally mature patients requiring total hip arthroplasty (primary or revision) due to osteoarthritis, post-traumatic/rheumatoid/psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis, avascular necrosis, acute traumatic fracture of femoral head/neck, failed previous hip surgery, or dislocation risks.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• POLARCUP® Dual Mobility System (K070278)
• Restoration™ ADM System (K072020)

Submission Summary (Full Text)

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11083116 (pg 1/3)

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a bold, sans-serif font, with a stylized graphic above the first letter. Below the word "Medacta" is the word "International" in a smaller font, and to the right of that is a symbol that looks like a plus sign.

510(k) Summary

APR - 7 2009

Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone [phone] FAX [phone]

Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: [phone] Fax: [phone] email: [e-mail]

Date Prepared: February 20, 2009

#### DEVICE INFORMATION

Trade/Proprietary Name: Versafit Cup Double Mobility Family

Common Name: Total Joint Replacement /Classification Name: Hip Joint, metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis

> 21 CFR 888.3353 Class II Device Product Code: MEH

Predicate Devices:

K070278 POLARCUP® Dual Mobility System K072020 Restoration ™ ADM System

## Product Description:

The Versafit Cup Double Mobility Acetabular Component is a two piece modular designed device consisting of the metal acetabular shell and a

Versafit Cup Double Mobility 510(k)

Section 5 - Page 2 of 4

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mating polyethylene liner. The metal component is machined from stainless steel M30NW conforming to ISO 5832-9. The outer surface of the metallic cup has two types of coatings: Ti plasma spray and HA/Ti plasma spray. The polyethylene liner is a double mobility liner made of standard UHMWPE conforming to ISO 5834. The liner has a minimum thickness of 5 mm. The acetabular component is available in 10 sizes which accept both CoCrMo and MectaCer BIOLOX forte Ceramic ball heads with diameters of 22 and 28 mm.

The polvethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafit cup Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation.

The Versafit Cup Double Mobility Family is designed to be used with the Medacta Total Hip Prosthesis' Quadra S Stems and ball heads (K072857, K073337, K080885, K082792).

#### Indications for Use:

The Versafit Cup Double Mobility Acetabular Component Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

- . Severely painful and/or disabled joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- Avascular necrosis of the femoral head .
- Acute traumatic fracture of the femoral head or neck .
- Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
- Dislocation risks .

#### Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the Versafit Cup Double Mobility Family was conducted in accordance with various international standards and FDA guidance documents.

The Versafit Cup Double Mobility family was tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performance of

Versafit Cup Double Mobility 510(k)

Section 5 - Page 3 of 4

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the Versafit Cup Double Mobility family is substantially equivalent to the predicate devices.

# Conclusion:

The data and information provided in this submission support the conclusion that the Versafit Cup Double Mobility Family are substantially equivalent to its predicate devices, POLARCUP® Dual Mobility System and Restoration™ ADM System with respect to intended use, design, materials, and operational principles.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medacta International, SA % NJK & Associates, Inc. Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, CA 92129

APR - 7 2009

Re: K083116

> Trade/Device Name: Versafit Cup Double Mobility Family Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: March 30, 2009 Received: April 3, 2009

Dear Ms. Kennel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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# Page 2 – Ms. Natalie J. Kennel

forth in 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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## Indications for Use Statement

## 510(k) Number (if known): K083116

Device Name: Versafit Cup Double Mobility Family

Indications for Use:

The Versafit Cup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.

The patient should be skeletally mature. The patient's condition should be due to one or more of:

- Severely painful and/or disabled joint as a result of osteoarthritis, post ● traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- Avascular necrosis of the femoral head ●
- Acute traumatic fracture of the femoral head or neck .
- Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Dislocation risks �

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carlae Busein Dor

Page · of

Division of General, Restorative. and Neurological Devices

510(k) Number K083116