Echo Bi-Metric Microplasty Hip System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized image of an eagle with three human profiles incorporated into its design. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 18, 2014 Biomet, Incorporated Ms. Julie Gantenberg, RAC Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581 Re: K143009 Trade/Device Name: Echo Bi-Metric Microplasty Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWZ, JDI, KWL, LWJ, KWY, OQG, OQH, OQI, PBI Dated: October 16, 2014 Received: October 20, 2014 Dear Ms. Gantenberg: 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 {1}------------------------------------------------ Page 2 - Ms. Julie Gantenberg, RAC 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143009 Device Name Echo Bi-Metric Microplasty Hip System Indications for Use (Describe) - 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2. Rheumatoid arthritis. - 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head - involvement, unmanageable using other techniques. - 5. Revision of previously failed total hip arthroplasty Porous coated components are intended for uncemented, biological fixation. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) SUMMARY A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 | Submitter Information | | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Name | Biomet Manufacturing Corp. | | Address | 56 East Bell Drive<br>Warsaw, IN 46581-0857 | | Phone number | (574) 267-6639 | | Fax number | (574) 371-1027 | | Establishment<br>Registration Number | 1825034 | | Name of contact<br>person | Julie B. Gantenberg, M.S., RAC | | Date prepared | December 5, 2014 | | Name of device | | | Trade or proprietary<br>name | Echo Bi-Metric Microplasty Hip System | | Common or usual<br>name | Hip Prosthesis | | Classification name | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis (21 CFR 888.3358) | | | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (21 CFR 888.3353) | | | Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis (21 CFR 888.3310) | | | Hip joint metal/polymer semi-constrained cemented prosthesis<br>(21 CFR 888.3350) | | | Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis (21 CFR 888.3360) | | | Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis (21 CFR 888.3390) | Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com Shipping Address: 56 East Bell Drive Warsaw, IN 46582 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image features the word "BIOMET" in a stylized, sans-serif font. The letters are bold and appear to be constructed from a series of parallel lines, giving them a three-dimensional effect. A registered trademark symbol is present to the upper right of the letter "T". # MANUFACTURING CORP. | Classification panel | Orthopedic | | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation | 21CFR 888.3358 | | | | 21 CFR 888.3353 | | | | 21 CFR 888.3310 | | | | 21 CFR 888.3350 | | | | 21 CFR 888.3360 | | | | 21 CFR 888.3390 | | | Product Code(s) | LPH, LZO, KWZ, JDI, KWL, LWJ, KWY, | | | | OQG, OQH, OQI, PBI | | | Legally marketed device(s)<br>to which equivalence is<br>claimed | Predicate Devices:<br>K070274 Echo Bi-Metric Press Fit Stem (Biomet) | | | | K110400 Taperloc® Complete Microplasty System (Biomet) | | | | K050251 Balance Hip System Microplasty Stem (Biomet) | | | | Reference Devices: | | | | K090757 Biomet Modular Femoral Revision System (Biomet) | | | | K133184 Ardis Interbody system (Zimmer) | | | | K130610 Sirius Femoral Stem (Biomet) | | | Reason for 510(k)<br>submission | Submission of Echo Bi-Metric Microplasty Hip System | | | Device description | The Echo Bi-Metric Microplasty Hip System consists of the<br>subject Echo Bi-Metric Microplasty Hip stem component and<br>legally marketed Biomet modular heads and/or acetabular<br>components for total hip or hemi hip arthroplasty. The subject hip<br>stem combines the design features of the standard length Echo Bi-<br>Metric Press-Fit Stems but offers a shortened stem length design<br>within the legally marketed shortened stem lengths using the<br>same previously cleared materials. | | | | Patient contacting, reusable implant specific instruments are<br>manufactured from stainless steel and include an aluminum<br>titanium nitride (AlTiN) PVD or titanium nitride (TiN) PVD<br>coating. | | | Intended use of the device | The proposed device system is an orthopaedic joint intended to<br>replace the damaged or diseased natural hip joint in total hip or<br>hemi hip arthroplasty to provide pain relief and restore function.<br>The hip system is modular in design, consisting of the subject<br>monolithic, femoral stem along with previously cleared, legally<br>marketed compatible Biomet modular heads and/or acetabular<br>components for total hip or hemi hip arthroplasty. | | | | Indications for use | 1. Non-inflammatory degenerative joint disease including<br>osteoarthritis and avascular necrosis.<br>2. Rheumatoid arthritis.<br>3. Correction of functional deformity.<br>4. Treatment of non-union, femoral neck fracture, and<br>trochanteric fractures of the proximal femur with head<br>involvement, unmanageable using other techniques.<br>5. Revision of previously failed total hip arthroplasty<br><br>Porous coated components are intended for uncemented,<br>biological fixation. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with a registered trademark symbol. Below that, the words "MANUFACTURING CORP." are written in a simple, sans-serif font. The technological characteristics of the Echo Bi-Metric Microplasty Hip System are the same as those of predicate devices (K070274, K110400 and K050251) in terms of design, material, and principle of operation with the exception of slight modifications as described in this 510(k). Differences include a shortened stem and rounded lateral shoulder when compared to the K070274 primary predicate. The Echo Bi-Metric Microplasty Hip Stems are proximally fitting, porous coated shortened stems for uncemented, biological fixation. Stem lengths are within the range of legally marketed short stems also cleared for biological fixation. The subject femoral stem utilizes the identical manufacturing processes as the predicates. The subject stem substrate and plasma spray coating are identical to that of K070274 and K090757. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K090757 and used in support of subject 510(k). The subject non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Non-clinical) section. Additionally, Biocompatibility information was provided in support of the implant specific instrument material. ## PERFORMANCE DATA ## SUMMARY OF NON-CLINICAL TESTS #### Performance Test Summary-New Device The following tests/were performed for the new Echo Bi-Metric Microplasty Hip System: - Range of Motion - Femoral Stem Proximal Fatigue - Femoral Stem Distal Fatigue ● - Biocompatibility (Implant Specific Instrument material) ● #### SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Biomet logo. The logo is in a sans-serif font and is a light gray color. There is a registered trademark symbol in the upper right corner of the logo. The text below the logo says "MANUFACTURING CORP." # MANUFACTURING CORP. Clinical Performance Data/Information: N/A ## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA No clinical testing was necessary for a determination of substantial equivalence. The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.