MEDACTA BIPOLAR HEAD

K091967 · Medacta International S.A. · KWY · Mar 2, 2010 · Orthopedic

Device Facts

• Record ID: K091967
• Device Name: MEDACTA BIPOLAR HEAD
• Applicant: Medacta International S.A.
• Product Code: KWY · Orthopedic
• Decision Date: Mar 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medacta® Bipolar Head is intended for use in combination with Medacta® Hip Prosthesis System and Mectacer femoral heads for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: · Femoral neck and trochanteric fractures of the proximal femur; · Osteonecrosis of the femoral head; · Revision procedures where other devices or treatments for these indications have failed.

Device Story

Medacta Bipolar Heads are orthopedic implants for hemiarthroplasty; consist of stainless steel outer shell and factory-assembled UHMWPE liner; designed to articulate with patient's acetabulum. Prosthetic femoral head locks into liner via elastic retaining ring. Used in conjunction with Medacta Hip Prosthesis System (Quadra S, H, R stems) and CoCrMo or Mectacer ceramic femoral heads. Implanted by orthopedic surgeons in clinical/hospital settings. Device restores hip joint function by replacing femoral head; provides stable articulation; benefits patients with fractures or osteonecrosis by enabling joint mobility.

Clinical Evidence

Bench testing only. Design verification testing conducted per international standards and FDA guidance on worst-case component sizes/designs. All testing met pre-defined acceptance criteria, demonstrating performance equivalent to predicate devices.

Technological Characteristics

Materials: Stainless steel outer shell, UHMWPE liner. Design: Bipolar head with elastic retaining ring locking mechanism. Dimensions: Outer diameters 40-52mm (1mm increments) for 22mm inner diameter; 44-60mm (2mm increments) for 28mm inner diameter. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring uncemented primary or revision hemiarthroplasty of the hip due to femoral neck/trochanteric fractures, osteonecrosis of the femoral head, or failed prior treatments.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• Apex Hip System Bipolar Head (K082468)
• Ortho Development Pivot Bipolar Head (K050966)
• Fixion™ Unipolar Modular Hemi-Hip System (K014072)
• PLUS Bipolar Heads (K982447)

Reference Devices

• Quadra S stem (K072857, K082792)
• Quadra H stem (K072857, K082792)
• Quadra R stem (K072857, K082792)
• CoCrMo femoral heads (K073337, K080885)
• Mectacer Femoral Heads (K073337, K080885)

Submission Summary (Full Text)

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

K.091967.

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 two black triangles above the "M" and "e". Below the word "Medacta" is the word "International" in a smaller, sans-serif font. To the right of the word "International" is a plus sign.

MAR - 2 2010

510(k) Summary

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]

June 26, 2009 Date Prepared:

### DEVICE INFORMATION

Trade/Proprietary Name: Medacta® Bipolar Heads

Hemi-hip prosthesis, uncemented Common Name: Classification Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis 21 CFR 888.3390 Class II Device Product Code: KWY

- Predicate Devices: K082468 Apex Hip System Bipolar Head K050966 Ortho Development Pivot Bipolar Head K014072 Disc-O-Tech Medical Technologies Ltd's Fixion™ Unipolar Modular Hemi-Hip System K982447 Plus Orthopedics PLUS Bipolar Heads
Medacta Bipolar Heads 510(k)

Section 5 - Page 2 of 4

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

#### Product Description:

The Medacta® Bipolar Head consists of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in an outer shell of stainless steel, designed to articulate directly in the patient's actebulum. The inner liner of UHMWPE articulates the prosthetic femoral head. The prosthetic femoral head is locked into place with an elastic retaining ring. The Medacta® Bipolar Head is available in outer diameters from 40 mm to 52 mm in 1 mm increments with an inner diameter that mates with a 22 mm diameter femoral head. The Medacta® Bipolar Head is also available in outer diameters from 44 mm to 60 mm in 2 mm increments with an inner diameter that mates with a 28 mm diameter femoral head. The Medacta® Bipolar Head may be used for hemiarthroplasty in conjunction with the following femoral stems which are part of the Medacta® Hip Prosthesis System - Quadra S, Quadra H and Quadra R stems. (K072857, K082792) The Medacta® Bipolar Heads may be used with the following femoral heads which are part of the Medacta® Hip Prosthesis System - CoCrMo femoral heads - and the ceramic femoral heads called the Mectacer Femoral Heads. (K073337, K080885).

The Medacta® Bipolar Head is a product suitable to use in a hemiarthroplasty procedure on any hip joint whose acetabular conditions are satisfactory.

#### Indications for Use:

The Medacta® Bipolar Head is intended for use in combination with Medacta® Hip Prosthesis System and Mectacer femoral heads for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

· Femoral neck and trochanteric fractures of the proximal femur:

- · Osteonecrosis of the femoral head:
· Revision procedures where other devices or treatments for these indications have failed.

#### Comparison to Predicate Devices

The Medacta® Bipolar Heads have the same indications for use as the predicate, Apex Hip System Bipolar Head (K082468) except for the specific femoral stems and heads with which it works. Medacta® Bipolar Heads are very similar in design, size range, and functionality as all of the bipolar predicates: Apex Hip System Bipolar Head, Ortho Development Pivot Bipolar Head (K050966) and Plus Orthopedics Bipolar Heads (K982447). They all are factory assembled with an UHMWPE liner which is not highly crosslinked. The Medacta® Bipolar Heads' outer metal shell, which is made of stainless steel, is the same type of material used in direct articulation with the natural acetubulum as the Disc-O-Tech Medical Technologies Ltd's Fixion™ Unipolar Modular Hemi-Hip System. Although the Disc-O-Tech predicate device is a unipolar head instead of bipolar head, the Medacta® Bipolar Heads have verv similar indication for use as the Disc-O-Tech predicate device.

Medacta Bipolar Heads 510(k)

Section 5 - Page 3 of 4

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

#### 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 Medacta® Bipolar Head was conducted in accordance with various international standards and FDA guidance documents.

The Medacta® Bipolar Head 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 the Medacta® Bipolar Head is substantially equivalent to the predicate devices.

#### Conclusion:

The data and information provided in this submission support the conclusion that the Medacta® Bipolar Head is substantially equivalent to its predicate devices, Apex Hip System Bipolar Head, Ortho Development Pivot Bipolar Head and Plus Orthopedics Bipolar Head with respect to intended use, design, and operational principles. The Medacta® Bipolar Head is substantially equivalent to its predicate, the Disc-O-Tech Medical Technologies Ltd's Fixion™ Unipolar Modular HemiHip System with respect to its outer shell material and tribological effect.

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

# 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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

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

MAR - 2 2010

Re: K091967

Trade/Device Name: Medacta Bipolar Heads Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: January 25, 2010 Received: January 28, 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. Iisting 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.

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

Page 2 - Ms. Natalie J. Kennel

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 eltection ic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-11050.

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/ucn1118809.html br 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 Pre 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 the [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millican

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

Enclosure

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

## Indications for Use Statement

510(k) Number (if known):

): K09467

Device Name: Medacta® Bipolar Heads

Indications for Use:

The Medacta® Bipolar Head is intended for use in combination with Medacta® Hip Prosthesis System and Mectacer femoral heads for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

· Femoral neck and trochanteric fractures of the proximal femur;

· Osteonecrosis of the femoral head;

• Revision procedures where other devices or treatments for these indications have failed.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Anita for mxn
(Division Sign-Off)

Page of

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

510(k) Number K091967