VERSAFITCUP CC TRIO-ADDITIONAL LINERS

K120531 · Medacta International · LZO · Apr 18, 2012 · Orthopedic

Device Facts

• Record ID: K120531
• Device Name: VERSAFITCUP CC TRIO-ADDITIONAL LINERS
• Applicant: Medacta International
• Product Code: LZO · Orthopedic
• Decision Date: Apr 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The hip prosthesis is designed for cementless use in total hip arthroplasty 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 where sufficient bone stock is present.

Device Story

Versafitcup CC Trio - Additional Liners are acetabular components for total hip arthroplasty; designed for use with Medacta Total Hip Prosthesis System (femoral stems, modular heads). Liners consist of HighCross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Components are supplied sterile for single-use. Surgeons implant these devices during hip replacement procedures to restore joint function and alleviate pain in patients with degenerative or traumatic hip conditions. Device provides bearing surface for femoral head; facilitates articulation within acetabular shell. Benefits include improved joint mobility and pain reduction.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via comparison to worst-case predicate liners, specifically assessing range of motion, liner-to-shell connection stability, and wear characteristics.

Technological Characteristics

Acetabular liners composed of HighCross (HXUHMWPE). Designed for cementless fixation in total hip arthroplasty. Supplied sterile for single-use. No electronic components or software.

Indications for Use

Indicated for skeletally mature patients requiring primary or revision total hip arthroplasty due to osteoarthritis, post-traumatic/rheumatoid/psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis, avascular necrosis, acute traumatic fracture, or failed previous hip surgery (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement) with sufficient bone stock.

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 CC Trio (K103352)
• Mpact Acetabular System (K103721)
• Versafitcup Double Mobility Highly Crosslinked (K092265)

Reference Devices

• Quadra S, H, R, and C Stems (K072857, K073337, K080885, K082792, K083558, K112115)
• AMStem femoral stems (K093944, K103189)

Submission Summary (Full Text)

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K120531

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APR 1 8 2012

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## 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: February 10, 2012

# DEVICE INFORMATION

Trade/Proprietary Name: Versafitcup CC Trio - Additional Liners Common Name: Acetabular Liners Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

> 21 CFR 888.3353 Class II Device Product Codes: ŁZO, MEH

Predicate Devices: K103352 Versafitcup CC Trio, Medacta International K103721 Mpact Acetabular System, Medacta International K092265 Versafitcup Double Mobility Highly Crosslinked, Medacta International

Versafitcup CC Trio - Additional Liners

Section 5 - Page 2 of 4

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120531

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### Product Description

The Versafitcup® CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, K083558, and K112115). The AMStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944, K103189). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup® CC Trio acetabular components that are the subject of this 510(k) consist of two new flat fixed liners that are made of HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE).

All the Versafitcup® CC Trio components are supplied sterile in single-use individual packages.

## Indications for Use

The hip prosthesis is designed for cementless use in total hip arthroplasty 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 where sufficient bone stock is present.

#### Comparison to Predicate Devices

The Versafitcup CC Trio - Additional Liners have the same intended use as the previously cleared Versafitcup CC Trio (K103352). The Versafitcup CC Trio - Additional Liners have the same material and are similar in size to the liners cleared in the predicate devices.

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# Performance Testing

The Versafitcup CC Trio - Additional Liners were compared to the worst case liners of the predicate devices in regards to the mechanical tests applicable to these products including range of motion, instability of connection between liner and acetabular shell, and wear. Since the Versafitcup CC Trio - Additional Liners are less critical than the worst case of the predicate devices, the Versafitcup CC Trio - Additional Liners do not introduce any new issues in regards to safety and effectiveness.

#### Conclusion:

Based on the above information, the Versafitcup CC Trio - Additional Liners can be considered substantially equivalent to its predicate devices.

## Versafitcup CC Trio - Additional Liners

Section 5 - Page 4 of 4

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

APR 1 8 2012

Re: K120531

Trade/Device Name: Versafitcup CC Trio - Additional 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: LZO, MEH Dated: March 21, 2012 Received: March 22, 2012

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 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

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## Page 2 -- Mr. Adam Gross

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,

FOR Pete O

Mark N. Melkerson Dep Lenda

Director Division of Surgical, Orthopedic

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120531

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# Indications for Use

510(k) Number (if known):

Device Name: Versafitcup CC Trio - Additional Liners

Indications for Use:

The hip prosthesis is designed for cementless use in total hip arthroplasty 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 where sufficient bone stock is present.

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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510(k) Number

510(k) Number K120531