MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD

{0}------------------------------------------------ l 4 l Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features a stylized font. The letters are bold and blocky, with the "O" in "Biomet" being a perfect circle. JAN 2 8 2005 # 510(k) Summary | Applicant/Sponsor: | Biomet Manufacturing Corporation<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0587 | |--------------------|-------------------------------------------------------------------------------------------------| |--------------------|-------------------------------------------------------------------------------------------------| Kacy Arnold, RN, MBA Contact Person: Regulatory Affairs Specialist Telephone: 574-267-6639 Fax: 574-372-1683 Proprietary Name: Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Head Common Name: total shoulder replacement components ### Classification Name: - assmeation Name. 1) Shoulder joint metal/polymer non-constrained cemented prosthesis (888.3650) ### Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hoad - y Marketed Devices TO Willen Budbeant.it Surface (EAS) Humeral Head (Biomet) - . K032895: Bi-Angular® Humeral Head (Biomet) . - K032895: BlPAngular Tianicial Humeral Replacement System (Biomet) K033280: Mosaic™ Proximal Humeral Replacement System (Biomet) ● - K992899: Bio-Modular® Offset Humeral Head (Biomet) . Device Description: The Mosaic™ components are made of Co-Cr-Mo per ASTM F 75 and are Device Description: The Prosac componenes and mass offset modular designs are used to wailable in a non-modular proximal body and an EAS offset modular designs are used wallable in a non-modular proximal bone surface or with cleared glenoid components. indications for Use: The Mosaic™ Non-modular Proximal Body and EAS Offiset Modular Humeral Indications for Use. The Nosale - Non mouth. I vint replacement procedures in cases of: Heads are for use in primary and revision shoulder joint replacement of the processor - are for use in primary and revision shoulder Joint replacement of the mascular necrosis . - Rheumatoid arthritis . - Revision where other devices or treatments have failed . - Correction of functional deformity . - Correction of fullchonal Gelonnity Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral . head (shoulder), which are unmanageable using other treatment methods - Oncology applications . Summary of Technologies: Mosaic™ Non-modular Proximal Body and Exticulating Surface Summary of Technologies. Mosale - Non mound. Proximal 2007 (EAS) Offset Modular Humeral Heads is identical in materials and processing as the predicate device. Non-Clinical Testing: Non-clinical testing demonstrated substantial equivalence between this device and the predicate devices. Clinical Testing: Clinical testing was not used to establish substantial equivalence. All trademarks are property of Biomet, Inc. {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 three lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 8 2005 Kacy Arnold Regulatory Affairs Specialist Biomet Manufacturing Corporation 56 East Bell Drive Warsaw, IN 46581 Re: K042321 Device Name: Mosaic Non Modular Proximal Body and EAS Offset Modular Humeral head Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/ polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT Dated: 1/17/05 Received: 1/18/05 Dear Ms. Arnold: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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. FIDA 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); 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. {2}------------------------------------------------ Page 2 - Kacy Arnold This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Madin M. Millerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Device Name: Heads #### Indications For Use: The Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for rne in primary and revision shoulder joint replacement procedures in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - · Revision where other devices or treatments have failed - · Correction of functional deformity - Conceasin of ranicuonal consic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods - · Oncology applications | Prescription Use | <b>X</b> | AND/OR | Over-The-Counter Use ______ | |-----------------------------|----------|--------|-----------------------------| | (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices | 510(k) Number | K042321 | |---------------|---------| |---------------|---------| Page 1 of 1