MODIFICATION TO PASS SPINAL SYSTEM

{0}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness - (1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Encore Orthopedics, Inc. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Joanna Droege February 7, 2002 - Trade or proprietary device name: PASS Spinal System (2) Pedicle screw spinal system Common or usual name: Class II Classification name: - (3) Legally marketed predicate device: PASS Splnal System (K001024) ## (4) Subject device description: The PASS Spinal System consists of pedicle screws, rod-plates, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The additional components that are the subject of this Special 510(k) submission are 04.5mm polyaxial pedicle screws and crosslinks (Exhibit I). The pedicle screws are the same design as the polyaxial screws cleared in K001024. The crosslinks are nut, rod and clamp assemblies that hook onto the rods of the assembled PASS Spinal System (K001024) to provide torsional stability to the construct. #### (5) Sublect device intended use: The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fysion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological Impairment, fracture, dislocation, scollosis, splnal turnor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is Intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft 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 posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for hook fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformitles (scoliosis, kyphosis and lordosis), turnor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery. #### (6) Performance data: The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. ## Basis for substantial equivalence: (7) The PASS Spinal System 4.5 mm Screws and Crosslinks is similar in design, materials and indications to the PASS Spinal System (K001024). {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 a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 4 2002 Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758 K020236 Re: Trade Name: PASS Spinal System Regulatory Number: 21 CFR 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: January 21, 2002 Received: January 23, 2002 Dear Ms. Droege: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 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 Devices: General regulation (21 CFR Part 820) and that, 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: 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 regulations. {2}------------------------------------------------ Page 2 - Ms. Joanna Droege 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours. Miriam C. Provost for 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 {3}------------------------------------------------ 510(k) Number (if known): _ KO20236 PASS Spinal System 4.5 mm Screws and Crosslinks Device Name: Indications For Use: # PASS Spinal System 4.5 mm Screws and Crosslinks Indications For Use The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft 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 posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for hook fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondification disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use | | |------------------|-----------------------------------------|----|----------------------|--| |------------------|-----------------------------------------|----|----------------------|--| (per 21 CFR 801.109) (Optional Format 1-2-96) | Miriam C. Provost | |----------------------------------| | (Division Sign-Off) | | Division of General, Restorative | | and Neurological Devices | | 510(k) Number | K020236 | |---------------|---------| |---------------|---------|