KAPSS SPINAL SYSTEM

{0}------------------------------------------------ ## 510(k) Summary 15 October 2010 Date: Sponsor: Contact Person: Proposed Trade KAPSS® Spinal Svstem Name: Device Classification Class II Orthosis, spinal pedicle fixation / Spinal interlaminal fixation orthosis Classification Name: Regulation: 888.3070 / 888.3050 Device Product MNI, MNH / KWP Code: Device Description: The KAPSS® Spinal System consists of longitudinal members (rods), anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety Intended Use: Materials: Predicate Devices: 4518855 Page 1/2 Robert Reid Inc. 4-22-2, Koishikawa, Bunkyo-ku Tokyo 112-0002 Japan Phone +81-3-3830-7375 Fax +81-3-3830-7376 Teiji Nakamura, Marketing Director OCT 1 5 2010 of sizes to accommodate differing anatomic requirements. The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. The system is also intended for posterior, non-pedicle fixation for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture. dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. The KAPSS® Spinal System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Page 1 of 2 {1}------------------------------------------------ K0938833 Page 2/2 ### Technological Characteristics: The KAPSS® Spinal System possesses the same technological characteristics as the predicate devices. These include - · intended use (as described above), - . basic design (rod-based fixation system having monoaxial and polyaxial pedicle screws and various hook shapes and sizes), - material (titanium alloy) and . - · sizes (rod and screw sizes are encompassed by those offered by the predicate systems) . The fundamental scientific technology of the KAPSS® Spinal System is the same as previously cleared devices. #### Performance Data: Static and dynamic compression bending tests and static torsion tests were performed on KAPSS® Spinal System constructs according to ASTM F1717. The mechanical test results demonstrated that KAPSS® Spinal System performs as well as or better than the predicate devices. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three parallel lines curving upwards, with a wavy line beneath them. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Robert Reid Inc. % Backroads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026-2141 Re: K093833 Trade/Device Name: KAPSS® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: October 10, 2010 Received: October 12, 2010 Dear Dr. Warden: We have reviewed your Section 510(k) premarket 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 FDA has made a determination that your device complies with other requirements of the Act OCT 15 2010 {3}------------------------------------------------ Page 2 - Karen E. Warden, Ph.D. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Barbar Buettn Mark N. Melkerson J Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 7. Indications for Use Statement 510(k) Number: | | 201333 Device Name: KAPSS® Spinal System Indications for Use: K095833 OCT 1 5 2010 The KAPSS® Spinal System is designed to provide immobilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. The system is also intended for posterior, non-pedicle fixation for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. Prescription Use X AND/OR Over-the-Counter Use (21 CFR 801 Subpart D) AND/OR --- (21 CFR 801 Subpart D) (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) Divi: Sign. of (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices Kog 3833 510(k) Number. Page 13