BONE PLATE WITH CABLES

{0}------------------------------------------------ 510(K) Summary ડ. ## Pioneer Laboratories 510(K) Notification Summary SEP 1 0 1997 For Bone Plate with Cables ### Administrative Information Manufacturer Identification and Sponsor: Pioneer Laboratories 375 River Park Circle Marquette, MI 49855-1781 Telephone: 906-226-9909 FAX: 906-226-9932 Official Contact: Burns Severson Vice President, Regulatory Affairs/Quality Assurance 6/9/97 Date Prepared: #### Device Identification Proprietary Name: Bone Plate with Cables Common Name Bone Plate | Classification Name and Reference: | | |------------------------------------|--------------| | Plate, Fixation, Bone: | | | Regulation Number: | CFR 888.3030 | | Classification Number: | 87 HRS | | Cerclage, Bone Fixation: | | | Regulation Number: | CFR 888.3010 | | Classification Number: | 87 JDQ II | Devices on which substantial equivalence is claimed: Dall-Miles Cable Grip System, Broad Bone Plate and Pioneer Laboratories Bone Plate with Cerclage Cables. ﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﻴﻞ ﺍﻟﻤﺘ 1 of 2 {1}------------------------------------------------ දෙකු පොලි 2 of 2 ### Device Description The Bone Plate with Cable's device consists of a bone plate with transverse holes for . passage of multifilament cables. A cable is passed through the transverse bone plate hole, and then through a crimp. The crimp is typically positioned adjacent to the plate. The . cable is locked into a tensioning device and tightened which applies compression to the plate and bone. The crimp and cable are then crimped with a crimping tool to lock the cable in place. Excess cable is cut and removed. Additional cables of the same system type maybe applied as required. ### Intended Use The Bone Plate with Cable's device is indicated for use where wire, cable, or band cerclage is used in combination with bone plates. The system is designed to provide increased compression as compared to only a bone plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments. The Bone Plate with Cable's device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the bone plate. ### Technological Characteristic Compared to Predicate Device All the devices use cables, crimps, and a bone plate as a system used for long bone fracture fixation. Each system uses a tensioner and crimp to apply compression, and lock the cable. The Dall-Miles Broad Bone Plate device places the rectangular crimp and cable over the bone plate. The Pioneer Laboratories Bone Plate with Cerclage Cables device has the crimp internal to the Bone Plate with Cable's device has the oval crimp adjacent to the plate with the cable passing through a hole in the plate. #### Performance Data The Bone Plate with Cable's device was predicated on the use of stainless steel, wire, Dall-Miles Broad Bone Plate, and the Pioneer Laboratories Bone Plate with Cerclage Cables. Based on tests of each of the systems the Bone Plate with Cable's device and the Pioneer Laboratories Bone Plate with Cerclage Cables exceed the loading values for wire systems. The loading values indicated that the Bone Plate with Cable's device is equivalent to the values of the Pioneer Laboratories Bone Plate with Cerclage Cable's system. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 0 1997 Mr. Burns Severson 'Vice President, Regulatory Affairs and Ouality Assurance Pioneer Laboratories 375 River Park Circle Marquette, Michigan 49855 K972223 Re: Bone Plate with Cable's Device Trade Name: Regulatory Class: II Product Codes: HRS and JDQ Dated: August 19, 1997 Received: August 22, 1997 Dear Mr. Severson: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory {3}------------------------------------------------ Page 2 - Mr. Burns Severson In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, [signature] Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Pioneer Laboratories # Bone Plate with Cables Device # Indications for Use The Bone Plate with Cable's device is indicated for use where wire, cable, or band cerclage is used in combination with bone plates. The Bone Plate with Cable's device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the bone plate. **Prescription Use** X (Per 21 CFR 801.109) signature