COPELAND MB RESURFACING HUMERAL HEADS

{0}------------------------------------------------ K010657 ## SEP 1 4 2001 ## CORPORATE HEADOUARTERS SUMMARY OF SAFETY AND EFFECTIVENESS Sponsor: Biomet, Inc. Airport Industrial Park Warsaw. Indiana 46580 Contact Person: Sara B. Shultz Telephone: (219) 267-6639 Fax: (219) 372-1683 Device: Copeland™M MB Resurfacing Humeral Heads Classification Name: prosthesis, shoulder, hemi-, humeral, metallic, uncemented Device Product Code: HSD (21 CFR 888.3690) MBF (unknown, recently down classified) Legally Marketed Devices To Which Substantial Equivalence is Claimed: Copeland TM Resurfacing Heads (K003044), Bi-Polar Shoulder (K002998), Bi-Polar Shoulder System (K991585), and Bio-Modular® Shoulder System (K992119). Intended Use: The Copeland™ MB Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance: - 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2) Rheumatoid arthritis - 3) Correction of functional deformity - 4) Reconstructable rotator cuff - 5) Treatment of fractures of the humeral head - 6) Traumatic arthritis For uncemented use only. Device Description: These devices are intended for use as a cementless fixation humeral replacement system that requires minimal bone resection. Copeland™ MB Resurfacing Humeral Heads can be used in hemi- or total shoulder replacement surgical procedures in > MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 > > I SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582 1 OFFICE 219.267.6639 ﺁﻻﺋﯽ ﮐﮯ ﺑﺎﺭﯼ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩﯼ ﮐﮯ ﺷﮩﺮ ﮐﮯ ﺷﮩﺮ ﮐﮯ ﺷﮩﺮ ﮐﮯ ﺷﮩﺮ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺷﮩﺮ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺷﮩﺮ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺷﮩﺮ ﮐﺎ ﺍﯾﮏ ﮐﮯ ﺷﮩﺮ ﮐ 219.267.8137 E-MAIL biomet@biomet.com {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "BIOMET" in a stylized font, with the letters connected and partially enclosed in boxes. Below the word "BIOMET" is the text "CORPORATE HEADQUARTERS" in a simple, sans-serif font. The text is evenly spaced and centered below the logo. Patients experiencing pain or disability of the gleno-humeral joint. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis if necessary due to the initial bone preservation. The humeral head components are available in four sizes - small, medium, large, and extra-large. The small, medium, and large humeral heads have the same radius of curvature, but the heights differ to cater for the range of anatomical sizes and offsets. The extra-large head has a larger radius of curvature to accommodate a patient with larger bone stock. The stem is tapered and fluted to provide maximum stability in the humerus. The components are manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75) and have a thin layer of plasma spray coating known as MacroBond™ on the non-articulating surface. There is a depression in the surface of the inner spherical radius of the head. This depression is intended for the location of the MacroBond™ Coating. The small, medium, and large humeral head components can be used with the BioModular Glenoids or Integrated Glenoids. The extra-large head can only be used with Biomet's BioModular Glenoids due to the larger spherical radius. Summary of Technologies: The Copeland™ MB Resurfacing Humeral Heads have the same design as the predicate Copeland™ Resurfacing Heads. The predicate devices are porous coated and cleared for cemented use, whereas, this submission contains a device with a MacroBond™ coating indicated for uncemented use. Clinical data was supplied to address these differences. Non-Clinical Testing: Finite Element Analysis was done to compare the Copeland™ MB Resurfacing Humeral Heads to the predicate, Copeland™ Resurfacing Heads. The MacroBond™ coating was characterized by performing various mechanical tests. Clinical Testing: Since 1990, 103 resurfacing heads have been implanted in cementless surface replacement arthroplasty of the shoulder. The minimum follow-up was 2 years. These clinical results provide data that demonstrates the substantial equivalence of the CopelandTM MB Resurfacing Humeral Heads > MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SUPPING ADDRESS 56 15, Bell Drive Warsaw, IN 46582 1 OFFICE 219.267.6639 l'AX 219.267.8157 E-MAIL blomet@biomet.com {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. SEP 1 4 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K010657/S001 Trade/Device Name: Copeland™M MB Resurfacing Humeral Heads Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: June 14, 2001 Received: June 18, 2001 Dear Ms. Shultz: 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, 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); 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. {3}------------------------------------------------ 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html Sincerely yours. Susa Walker, MD Image /page/3/Picture/5 description: The image shows a stylized drawing of a cursive letter. The letter has a loop at the top and a curved base. The drawing is simple and lacks detail. 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 {4}------------------------------------------------ Page 1 of 1 510 (k) Number (if known) : __________________________________________________________________________________________________________________________________________________ Device Name: Copeland™ MB Resurfacing Humeral Heads Indications For Use: The Copeland™ MB Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance: - 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2) Rheumatoid arthritis - 3) Correction of functional deformity - 4) Reconstructable rotator cuff - 5) Treatment of fractures of the humeral head - 6) Traumatic arthritis For uncemented use only. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | <div><div style="display:inline-block;"><svg height="20" width="20"><path d="M5 13 L15 3 L16 4 L6 14 Z" fill="black"></path></svg></div> OR Over-The-Counter-Use</div> (Optional Format 1-2-96) Division of General, Restorative and Neurological Devices | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | # K010657 | 000003