NEXT GENERATION RODDING SYSTEM

{0}------------------------------------------------ OCT 2 7 page page 1 of 2 ## IX. Summary of Safety and Effectiveness - SUBMITTER: United States Surqical A division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, CT 06856 - CONTACT PERSON: Luis Nesprido DATE PREPARED: August 12, 1999 - CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis Spondylolisthesis Spinal Fixation Device System - COMMON NAME: Titanium Spinal Rod System - PROPRIETARY NAME: Next Generation Rodding System - PREDICATE DEVICES: USS's Surgical Dynamics Rodding System - K983197 - INTENDED USE: The components of the Next Generation Rodding System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods ands screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spinę. The Indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, The Next Generation Rodding System is {1}------------------------------------------------ indicated for patients: (a) having severe spondylolisthesis (Grades 3 Indicated for patients. (a) having over receiving fusions using and 4) at the ES OF Johns; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) allached to the fumbar and sacrar spire the development of solid fusion mass. In addition, when used as a pedicle screw system, in the non-In addition, when used as a patients, the Next Generation cervical spine or skeictally indure porovide immobilization and Rodding System is intended to pn adjunct to fusion, in the treatment of the following acute and chronic instabilities of the theatment of the following abute and spine: degenerative spondylolisthesis thoracity, fumbar, and Subrar Spinst are simpairment, fracture, with objective condence en nothers, spinal tumor, and failed previous fusion (pseudoarthrosis). The material used is implant grade material that conforms to ASTM MATERIALS: The material used is implant gration for wrought Titanium alloy (Ti-6Al-4V). {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 27 1999 Mr. Luis Nesprido Regulatory Affairs Associate Regulatory United States Surgical Corporation 150 Glover Avenue 06856 Norwalk, Connecticut K992784 Re: Next Generation Rodding System Trade Name: Regulatory Class: II Regulatory Clabbry Clabbry, MNH, and MNI Frodder Sugust 13, 1999 Dated: Dear Mr. Nesprido: We have reviewed your Section 510(k) notification of intent to r the basis in moferenced above and we have determined the We have reviewed your sector 310(x) howe have determined the market the device referenced above and we indications for market the device referenced above and wo no market ons for device is substantially equivateli (ror encreated in interstate use stated in the enclosure) to devices marketed in interstate use stated in the encrosure) to de roos tment date of the commerce prior to May 20, 1978, or to devices that have been Medical Dovice Amendments, or to devices of the provisions of the provisions of the Medical Device Amendments, of to devisions of the Federal reclassified in accordance from to (Act). You may, therefore, Food, Drug, and Cosmetic Act (Rcc). Ioa may) market the device, subject to the general controls provisions of the Act market the device, subject to the general controls of the Act of the Act. The general controls provisions of the Act of the Act. The genefal concreation, listing of include requirements for annual registion, and include requirements for annaractice, labeling, and devices, good manufacturing practer. , prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II n the may be and the TIT (Premarket Approval), it may If your device is class III (Premarket Approval), it may (Special Controls) or class III (Premarket Approval), it may (Special Controls) of Craob I controls. Existing major be subject to such additional controls. can be found in the be subject to such addicionar concreason found in the Code of regulations affecting your actrosits 800 to 895. Federal Regulations, Title 21, Parts 800 to Commes Cou A Federal Regulations, ficte it, farts out of compliance with substantially equivalent uccements as requirement, as set the current Good Manufacturing (OS), for Medical the current Good namaractan Regulation (QS) for Medical forth in the Quality System Regulation (QS) and that forth in the Quality System (21 CFR Part 820) and that, Devices: General Legaractic (ons, the Food and Drug through periodic (QS) inspections, the essumptions through perrodic (gr) insperify such assumptions. Administration (FDA) will verify such in roqulat Failure to Administration (from will tommy result in regulatory comply with the CMP regulation may the further announce comply with the Gif reguration individual announcements action. In addition, FDA may publish further Please not Please note: action. In address.) In the Federal Register. concerning your device in the reactives ion submission does this response to your premaries that have under sections 531 not affect any obligation you might under the Floctronic not afrect any obligation you mees under the Electronic through 542 of the Act Iol devices andor one of other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Mr. Luis Nesprido 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) 143-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" a Sincerely yours, f Celia 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}------------------------------------------------ ## IV. Indications for Use 510(k) Number (if known): _ ≤ 9927784 Device Name: Next Generation Rodding System ## Indications For Use: The components of the Next Generation Rodding System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/liac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/lijac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Next Generation Rodding System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass. In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Next Generation Rodding System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: (Per 21 CFR 801.109) 510kk) Nirmha United States Surgical Page 8 Premarket Notification (Please do not write below this line - continue on another page if needed)