VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS

K092265 · Medacta International S.A. · MEH · Mar 12, 2010 · Orthopedic

Device Facts

• Record ID: K092265
• Device Name: VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
• Applicant: Medacta International S.A.
• Product Code: MEH · Orthopedic
• Decision Date: Mar 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Versafitcup™ 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

Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are orthopedic implants for total hip arthroplasty; designed for cementless use. Liners are manufactured from highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE) via controlled radiation exposure and stabilizing heat treatment. Device articulates freely within a metal acetabular cup; intended to provide increased wear resistance compared to standard UHMWPE. Used by orthopedic surgeons in clinical settings; compatible with Medacta Quadra Stems and ball heads. Output is a physical bearing surface facilitating joint articulation; aids in restoring hip function and reducing pain for patients with degenerative or traumatic joint conditions.

Clinical Evidence

Bench testing only. Design verification testing conducted per international standards and FDA guidance. Simulator wear data demonstrated increased wear resistance for HXUHMWPE compared to standard UHMWPE. No clinical data provided.

Technological Characteristics

Material: Highly crosslinked UHMWPE meeting ASTM F648. Manufacturing: Radiation crosslinking followed by stabilizing heat treatment. Design: Acetabular liner for cementless total hip arthroplasty. Connectivity: None (mechanical implant). Sterilization: Standard methods consistent with predicate.

Indications for Use

Indicated for skeletally mature patients undergoing primary or revision total hip arthroplasty due to osteoarthritis, post-traumatic/rheumatoid/psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis, avascular necrosis, acute traumatic fracture of femoral head/neck, failure of 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

• Versafitcup™ Double Mobility System (K083116)
• Trilogy Longevity Constrained Liner (K071718)
• Reflection 3 Acetabular System (K061253)
• Epsilon™ Durasul® Constrained Acetabular liner (K030923)

Reference Devices

• Trident® Crossfire® Polyethylene Liners (K021911)
• DePuy Marathon™ Crosslinked Polvethylene Acetabular Cup Liners (K994415)
• Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Liners (K990135)

Submission Summary (Full Text)

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K092265- II'/3

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, followed by a plus sign.

# Traditional 510(k) Summary

MAR 1 2 2010

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

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

Sept. 24, 2009 Date Prepared:

# DEVICE INFORMATION

| Trade/Proprietary Name: | Versafitcup™ Double Mobility Highcross®<br>HXUHMWPE Liners |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name:<br>Classification Name: | Total Joint Replacement<br>Hip Joint, metal/ceramic/polymer semi-constrained<br>cemented or non-porous uncemented prosthesis |
| | 21 CFR 888.3353<br>Class II<br>Device Product Code: MEH |
| Predicate Devices: | K083116 Versafitcup™ Double Mobility System<br>K071718 Trilogy Longevity Constrained Liner<br>K061253 Reflection 3 Acetabular System<br>K030923 Epsilon™ Durasul® Constrained<br>Acetabular liner |

Versafitcup™ DM HXUHMWPE Liners 510(k)

Section 5 - Page 2 of 4

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K092265 #2

K021911 Trident® Crossfire® Polyethylene Liners K994415 DePuy Marathon™ Crosslinked Polvethylene Acetabular Cup Liners K990135 Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Liners

#### Product Description:

The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are a modification of the polyethylene liners to be made of a highly crosslinked ultra high molecular weight polyethylene. The liners are identical in sizes, dimensions and functionality as the standard UHMWPE liners which were cleared as part of the original 510(k) submission. The Highcross® UHMWPE liners are manufactured from UHMWPE that has been crosslinked by controlled exposure to radiation followed by a stabilizing heat treatment prior to machining of the liners. The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to wear. The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648.

There is no change to the metal acetabular cup of the Versafitcup™ Double Mobility system.

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

The Versafitcup™ Double Mobility Family including the new highly crosslinked UHMWPE liners are designed to be used with the Medacta Total Hip Prosthesis' Quadra Stems and ball heads (K072857, K073337, K080885, K082792).

#### Indications for Use:

The Versafitcup™ 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, . traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis,
- Congenital hip dysplasia .
- Ankvlosing spondylitis .
- Avascular necrosis of the femoral head .
- Acute traumatic fracture of the femoral head or neck .

Versafitcup™ DM HXUHMWPE Liners 510(k)

Section 5 - Page 3 of 4

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K092265 #3/3

- Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- 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 Versafitcup™ Double Mobility Highcross® HXUHMWPE liners was conducted in accordance with various international standards and FDA guidance documents.

The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners were tested as part of design verification to written protocols with pre-defined acceptance criteria. As applicable, 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 the Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are substantially equivalent to the predicate device.

## Basis of Substantial Equivalence

The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners have the following similarities to the standard UHMWPE liners cleared in K083116: same intended use, same raw material, same method of manufacture, same design, same sizes and dimensions, same mating components, and same sterilization and packaging methods. The new highly crosslinked liners have an increased resistance to wear as shown in simulator wear data. These in vitro results have not been correlated to clinical experience. The method of highly crosslinking of the UHMWPE is similar to that used in other cleared total hip replacement systems.

## Conclusion:

The data and information provided in this submission support the conclusion that the Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are substantially equivalent to its predicate device, Versafitcup™ Double Mobility family with respect to intended use, design, and operational principles. The use of highly crosslinked UHMWPE is similar to that used in other cleared total hip replacement systems.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

MAR 1 2 2010

Re: K092265

Trade/Device Name: Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: Class II Product Code: MEH Dated: February 23, 2010 Received: February 26, 2010

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. 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

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Page 2 – Ms. Natalie Kennel

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/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Akbarmeup

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 Statement

#### 510(k) Number (if known): K092265

Device Name: Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners

### Indications for Use:

The Versafitcup™ 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 _____________________________________________________________________________________________________________________________________________________________

OR Over-The-Counter Use
(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)

Smithe for mxn
(Division Signer)

Division of Servical, Orthopedic, and Restorative Devices

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510(k) Number K092265