MPACT EXTENSION

{0}------------------------------------------------ # K122641 (pg 1/37 Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two black triangles pointing upwards, followed by the word "edacta" in lowercase letters. Below the logo is the word "International" and a small cross symbol. SEP 28 2012 #### 510(k) Summary Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66 Contact Person: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com Date Prepared: 08/31/2012 ### DEVICE INFORMATION Trade/Proprietary Name: Mpact Extension Common Name: Total Hip Acetabular Components Class II Classification Name: 21 CFR 888.3358 - Hip joint, femoral metal/polymer/metal semiconstrained porouscoated uncemented prosthesis Device Product Code: LPH 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Device Product Code: LZO Predicate Devices: K103721 Mpact Acetabular System, Medacta International K033338 Pinnacle Revision System, Depuy Orthopaedics Mpact Extension 510(k) Section 5 - Page 2004 {1}------------------------------------------------ #### Product Description The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension acetabular components that are the subject of this 510(k) consist of a multi-hole or rim-hole shell (Ti-6Al-4V, ASTM F136 and Ti, ASTM F1580 porous coating), a fixed liner in sizes "J" and "K" that is made of ultra-high molecular weight polyethylene (UHMWPE ISO 5834-2 Type1) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE), and a cortical bone screw, flat head (Ti-6AJ-4V, ISO 5832-3). #### 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, posttraumatic t arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia. ankylosing spondvlitis. - 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 indications for use of the Mpact Extension are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the Mpact Extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. #### 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 Mpact Extension was conducted in accordance with various international standards and FDA guidance documents. The Mpact Extension was tested as part of design verification to written protocols with pre- Mpact Extension 510(k) {2}------------------------------------------------ defined acceptance criteria. The Mpact Extension testing was conducted on the worst case component size and option/design. The design verification testing included pull-out, lever-out and torsional stability of the modular connection of the fixed liner to the metal shell, coating validation, metal shell deformation resistance during impaction, range of motion, wear, and bone screw testing. The testing met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices. K122641 (pg 313) #### Conclusion: Based on the above information, the Mpact Extension can be considered as substantially equivalent to its predicate devices. ### Mpact Extension 510(k) Section 5 - Page 4 A {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SEP 28 2012 Medacta International % Medacta USA Mr. Adam Gross 4725 Calle Quetzal, Unit B Camarillo, CA 93012 Re: K122641 Trade/Device Name: Mpact Extension 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, LPH Dated: August 29, 2012 Received: August 29, 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 I va may, alcreater, mains 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 If your device is eadditional 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 i lease be activities that i Drivistian that your device complies with other requirements of the Act that I DA has made a acterinalitions administered by other Federal agencies. You must {4}------------------------------------------------ #### Page 2 - Mr. Adam Gross 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 (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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark McMullen 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 510(k) Number (if known): K(22641 (pa 1/1) Device Name: Mpact Extension 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, posttraumatic . arthritis, rheumatoid arthritis or psoriatic 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) Af (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices Mpact Extension 510(k) August 27, 2012 K122641 510(k) Number Section 4 - Page 2 of 2