BASIS SPINAL SYSTEM

{0}------------------------------------------------ K06008 # FEB 1 3 2006 ## BASISTM Spinal System - Crosslink® Plates Summary of Safety and Effectiveness February 2006 - Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 - Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs - Proposed Proprietary Trade Name: BASIS™ Spinal System II. - Classification Name(s)/Product Code(s): 888.3050, 888.3060, 888.3070 III. Classification Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Pedicle Screw Spinal System Product Codes: KWQ, KWP, MNH, MNI #### Product Description IV. The BASISTM Spinal System consists of a variety of shapes and sizes of hooks, screws, bolts, nuts, plates, and vertebral body spacers, as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case. BASIS™ hooks are intended for posterior use only. The BASIS™ Spinal System implant components are made from medical grade titanium alloy. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct. BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the BASIS™ Anterior Thoracolumbar Plate, the BASIS™ Multi-Axial Screws, or the BASIS™ Fixed Angle Screws must be used with the BASIS™ Vertebral Body Spacers. To achieve best results, do not use any of the BASIS™ components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic implants, none of the BASIS™ components should ever be reused under any circumstances. The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System. {1}------------------------------------------------ ### Indications V. The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., multations: Spondyformanons, washing (11), seudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS Except for noons, when asse the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion. When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be when assured as a versory oes to aid in surgical correction and stabilization of the spine. The device is used in corportion procedures would spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Danek BASIS™ Anterior Thoracolumbar Plates, Multi-Axial Screws, or Fixed Angle Screws. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft. Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Posterior surgical implantation. The BASIS™ Anterior Cervical Plates are intended for posici in burged intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only. #### Substantial Equivalence VI. VI. Components to be substantially equivalent to EQUATION™ Fixation System Components previously cleared in K013962. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve and converge at the bottom, resembling a stylized human figure. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol. FEB 1 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 Re: K060081 : K060081 Trade/Device Name: BASIS™ Spinal System Frade/Don Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Regulatory - KWP, KWQ, MNH, MNI Dated: January 9, 2006 Received: January 10, 2006 Dear Dr. Treharne: We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section > Iv(x) prematic is substantially equivalent (for the indications referenced above and have determined the device andrested in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally intarced teched as a discal Device Amendments, or to commerce prior to May 28, 1976, the enactment with the provisions of the Fede commerce prior to May 28, 1976, the elacance with the provisions of the Federal Food, Drug. devices that have been reclassified in accordance with the provisions of IMA) devices that have been reclassified in accordance whe are approval application (IPMA). and Cosmetic Act (Act) that do not require approval applications of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to the general contra You may, therefore, market the device, subject to annual registration, listing of general controls provisions of the Act include requiret mishranding and general controls provisions of the Act merade requirement. 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 If your device is classified (see aove) nito existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations affe may be subject to such additions. Existing mays regal to 898 In addion, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addion, FDA ma be found in the Code of Federal Regarders in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substitition with other requirements of the Act that FDA has made a determination that your device addres accepcies. You must that FDA has made a determination mac your arrest by other Federal agencies. You must or any Federal statutes and regulations and united to: registration and listing (21 comply with all the Act's requirements, and comply with all the Act S requirements, merdamg, out her mintenents as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Richard W. Treharne, PhD forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1650. product Taulation control provisions (Decisions (Device as described in your Section 5 10(k) I ms letter will anow you to ocgin manuting of substantial equivalence of your device to a legally premarket nother in the PDA midning of backman of the evice 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 If you desire specific advice for Jour ac 10-10-20120. Also, please note the regulation entitled, a Colliact the Office of Complance an (21 t notification" (21CFR Part 807.97). You may obtain Misolanding by relevelee to promantonionship.itities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-204 to Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sor Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of ____________________________________________________________________________________________________________________________________________________________________ February 2006 510(k) Number (if known): BASISTM Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; survatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, EXCEpt for noons, when used as an atter following indications: (1) spinal stenosis, (2) BASIS components are monded for the formities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion. When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to when used as a vertebrar body replaceming surgical correction and stabilization of the spine. The be used in corpectonly procedures to the under spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Specifically, DASID - Vertenal Booy of lates, Multi-Axial Screws, or Fixed Angle Screws. Dallek DASIS - Amerior Theraceral Body Spacers are intended to be used with bone graft. Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Nota Denc. The Drive - The BASIS™ Anterior Cervical Plates are intended for anterior cervical intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K060081 ﮩﺎﺋﮯ Page