POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185

{0}------------------------------------------------ # NOV 1 0 2003 K032607 ### PROPRIETARY INFORMATION -- LINVATEC CORPORATION August 21, 2003 # SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the PowerPro® Pneumatic System, 510(k) Number #### A. Submitter Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 #### B. Company Contact Laura D. Krejci, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX #### C. Device Name PowerPro® Pneumatic System Trade Name: Common Name: Powered surgical instrument and accessories/attachments Classification Names: Surgical instrument motors and accessories/attachments 878.4820 Bone cutting instrument and accessories 872.4120 Pneumatic cranial drill motor 882.4370 | Proposed Class: | II | |-----------------|--------------------| | Product Codes: | GET, DZI, HBB, KFK | {1}------------------------------------------------ # PROPRIETARY INFORMATION - LINVATEC CORPORATION Summary of Safety and Effectiveness PowerPro® Pneumatic 510(K) # August 21, 2003 Page 2 of 2 ### D. Predicate/Legally Marketed Devices | PowerPro® Electric System<br>Linvatec Corporation | 510(k) #K981269 | |---------------------------------------------------------|-----------------| | Hall® Surgical Series 4® System<br>Linvatec Corporation | 510(k) #K832187 | | Midas Rex Legend System<br>Medtronic Midas Rex | 510(k) #K020069 | ### ய் Device Description The PowerPro® Pneumatic System is a pneumatically powered system consisting of handpieces and attachments for cutting bone in various large and small bone procedures. The PowerPro® Pneumatic handpieces are pistol-grip handpieces. The handpieces utilize various attachments, such as blades, burs, drills and routers that are also used with Linvatec's PowerPro® Electric and Battery Systems. ### F. Intended Use The PowerPro® Pneumatic System consists of handpieces and attachments intended to be used for cutting, drilling, tapping, reaming, and driving screws and pins in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. ### Substantial Equivalence G. The PowerPro® Pneumatic System is substantially equivalent in design, function and intended use to the predicate devices named above. The PowerPro® Pneumatic System does not raise any new safety or effectiveness issues when compared to these similar devices. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing right, with three horizontal lines above them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 0 2003 Ms. Laura D. Krejci, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773 Re: K032607 Trade/Device Name: PowerPro® Pneumatic System Regulation Number: 21 CFR 872.4120, 878.4820, 882.4370 Regulation Name: Bone cutting instrument and accessories, Surgical instrument motors and Accessories/attachments, Pneumatic cranial drill motor Regulatory Class: II Product Code: DZI, HSZ, HBB Dated: August 21, 2003 Received: August 25, 2003 Dear Ms. Krejci: 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 (o 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. 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}------------------------------------------------ Page 2 - Ms. Laura D. Krejci, RAC 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 (301) 594-4659. 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/dsma/dsmamain.html Sincerely vours. Miriam C. Provost 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}------------------------------------------------ # PROPRIETARY INFORMATION - LINVATEC CORPORATION August 21, 2003 510(k) Number (if known): KO32609 Device Name: PowerPro® Pneumatic System Indications for Use: The PowerPro® Pneumatic System consists of handpieces and attachments intended to be used for cutting, drilling, tapping, reaming, and driving screws and pins in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use_ Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Miriam C. Provost Division of Ger neral. and Neurological Devices 510(k) Number K032607