SHIRAZ-ANTERIOR SYSTEM

{0}------------------------------------------------ Page 1 of 2 #### 510(k) Summary K033965 #### SUBMITTED BY Diane Johnson On Behalf of Spine Next America 8381 Dix Ellis Trail Suite 110 Jacksonville, FL 32256 December 19, 2003 Date Submitted: # CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME | Trade/Proprietary Name: | Spine Next SHIRAZ Anterior System | |-------------------------|----------------------------------------------| | Common/Usual Name: | Spinal Fixation System | | Classification Names: | Spinal intervertebral body fixation orthosis | #### PREDICATE DEVICE Moss Miami [K021880, cleared June 26, 2002]. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92 # DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION The Spine Next SHIRAZ Anterior System is designed to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies). All implants are manufactured from Titanium Alloy (Ti6A14V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832. #### INDICATIONS FOR USE The SHIRAZ systems include the SHIRAZ JAVA, the SHIRAZ Posterior, and the SHIRAZ Anterior System. The SHIRAZ JAVA system has been previously cleared. When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone {1}------------------------------------------------ Page 2 of 2 grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a pedicle screw fixation system, the SHIRAZ Systems are also intended to when used as a pediere serow intention of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or as an adjunct to rusion in the reading and sacral spine: degenerative spondylolisthesis with deformines of the moracie, fainous, and vant, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). When used as a posterior, noncervical hook, and/or sacral/ilias screws fixation system, or when used as a posterior, noncer roan areas, we fixation system, the SHIRAZ Systems are as an bi-factar anterior, and lordosis, fracture, loss of stability due to tumor, mitended to treat sconomis, sypholo answer and for failed fusion surgery or degenerative disc Spinal Stellosis, Spondyrouses, a with degeneration of the disc confirmed by patient history and radiographic studies). ### PERFORMANCE DATA Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 4 2004 Spine Next America C/o Ms. Diane Johnson Director, Regulatory Affairs 104 Greenwood Creek Road Queenstown, MD 21658 Re: K033965 Trade/Device Name: SHIRAZ Anterior System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 20, 2003 Received: December 22, 2003 Dear Ms. Johnson: We have reviewed your Section 510(k) promarket 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 I'DA 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. Diane Johnson This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leave will and in yourse FDA finding of substantial equivalence of your device to a legally prematice notineation. The 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 11 you desire specific acres at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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, 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}------------------------------------------------ # 510(k) Number (if known): K033965 Device Name: Spine Next SHIRAZ Anterior System, a portion of the SHIRAZ Systems. # Indications for Use for the SHIRAZ Systems: When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for when used as a pedicte screw intactor rydes 3 and 4) at the fifth lumbar - first sacran treatment of severe spondylonismesis (Grados by assion by autogenous bone (L)-ST) vertebrail John in skeleady mattar pabar and sacral spine (L3 to sacrum) with graring nating after the attainment of a solid fusion. When used as a pedicle screw fixation system, the SHIRAZ Systems are also intended to When used as a pedicie serew fixation by spinal segments in skettally mature patients. provide immobilization and stabilization of spinal segments instablilige or provide immoonization and stabilization of the following acute and chronic instabilities or as an adjunct to rusion in the teathern oracral spine: degenerative spondylolistiesis with deformites of the thoracte, fullibur, and succasion, scoliosis, kyphosis, kyphosis, objective oviders and failed previous fusion (pseudoarthrosis). When used as a posterior, noncervical hook, and/or sacral/iliac screws fixation systems are when used as a posterior, nonect road novel, we fixation system, the SHIRAZ Systems are as an bi-lateral anchor, inordois, and lordosis, fracture, loss of stability due to tumor, intended to treat sconosis, kyphosis and revously failed fusion surgery or degenerative disc spinal stenosis, spontyfonsmesis, a proviously ration of the disc confirmed by patient history and radiographic studies). # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Festorative, and Neurological Devices | Prescription Use (PER 21 CFR 801.109) | <span style="text-decoration: overline;">K033965</span> | |---------------------------------------|---------------------------------------------------------| | 51 | Over-The-Counter Use | i Optional Format 1-2-96