SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM

{0}------------------------------------------------ ## Summary of Safety and Effectiveness Information [510(k) Summary] K974525 MAR - 2 1998 SYNTHES (U.S.A.) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Barry E. Sands 11/6/97 Device: SYNTHES Spine Anterior Thoracolumbar Rod Clamp (ATKC) System compared to the Synthes Spine Antenor Thoracolumbar Locking Plate System (ATLP) and the Synthes Spine Universal Spinal Rod and Scew Fixation System (USS) cloured in K925351 and K922855, respectively. The Syathes Spine Anterior Thoracolumbar Rod Clamp (All'RC) System consists of a rod, a choice of three clamps, one bone screw and one serew. It is intended for use in stabilizing - · bone graft following anterior decompression of burst liactures. - verrebrectorny and vertebral body replacement in turnor patients. f - · anterior fusion following failed posterior lumbar surgery. - · anterior fusion following severe disc degenerative Disc. Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by hUstory and rulivyruphic studies - · correction of anterolateral locatic deformities for the spinc, lumber scollosis and peeudearthrosis of the thoracolumbar spine. This system is meaded for anterolateral littervertebral body screw fixasion/auculuncul to the T8 - LS spinc. The rod and set screw used in this system are identical to that of the USS. The bone screw is identival to that in the ATLP system. The rwo ends of two rods, of upprupriate length, are inserted into the two (unthreadod) holes of each clamp and locked into position by the set serews included in the construct is then placed on the anterolateral aspect of the spinal segment to be subilized. The cousunct is anached to the vertebral bodies by four 7.5mm self-tapping unicortical screws. All implantable ways are manufactured from cither CP timium, which conforms to ASTM Standard F67, or TAN, which conforms to ASTM F1795. The instruments used to attach the spine are made from various grades of Stainless Steel. The Anterior Thoracolumbar Rod Clamp (ATKC) System is indicated for the same clinical indications as that of the identified legally marketed predicate systems. Material to these systems as well. The implantable components are equivalent in terms of safety and effectiveness. In fact, the see screw and the 1. mm bone screw (with the exception of one leagh) and rouls are identical in design which country of the predicate devices. The surgical technique and instrumentation to implaat this system is equivalent in rems of safery and effectiveness. This system is provided non-sterile; moist heat sterilization is recommended Based on the above, the Syathes Spine Anterior Thoracolumbar Rod Clamp (ATRC) System is substantially equivalent to the Synthes Spine Anterior Thoracolumbar Lockung Plate System (ATLP) and the Synthes Spine Universal Spinal Rod and Sciew Firation System (USS). {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of an eagle. The eagle is depicted with three swooping lines that form its head and wings. The overall design is simple and recognizable, representing the department's role in public health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Barry E. Sands Manager, Regulatory Affairs SYNTHES Spine P. O. Box 0548 1690 Russell Road 19301 Paoli, Pennsylvania MAR - 2 1998 K974525 Re: Anterior Thoracolumbar Rod Clamp (ATRC) System Requlatory Class: II Product Code: KWQ December 1, 1997 Dated: Received: December 2, 1997 Dear Mr. Sands: We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act) . . to the general controls provisions of the Act and the limitations identified below. 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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f) (1) of the Act. FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly: - 1. You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the {2}------------------------------------------------ package insert must include the following statement, This device system is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."; - All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and - Pedicular screw fixation/attachment to the cervical, 3. thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note 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 Requlations. FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required. {3}------------------------------------------------ ## Page 3 - Mr. Barry E. Sands This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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, 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}------------------------------------------------ Page 1 of 1 510(K) Number (if known): NA Device Name: Synthes Spine Anterior Thoracolumber Rod Clauss (ATRC) System Indications for Use: The Synthes Spine Auterior Thoracolumbar Rod Clamp (ATRC) System consists of a rod, a choice of three clamps, one bone screw and one set screw. It is intended for use in stabilizing - · bone graft following anterior decompression of hurst fractures. - · vertebrectorny and vertebral body replacement in turnor patients. - · anterior fusion following failed posterior lumber surgery. - · suterior following severe disc degeneration. Degenerative Dise Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies - · correction of anterolateral lordone deformities for the spine, lumbar scolliosis and pseudoardirosis of the thoracolumitm spine. This system is intended for anterolaters interventebral hady secew tixation/attachment to the T8 - LS spine. (PI.F.A.SF. DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IT NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use brotts **Division Sign-Off)** Division of General R 810(k) Number K97-1525