TRI-FIX SPINAL FIXATION SYSTEM

{0}------------------------------------------------ 013403 page 1 of 3 # Section 7 - 510(k) Summary of Safety and Effectiveness | <b>7.1</b><br><b>Statement</b> | This summary of 510(k) safety and effectiveness information is being submitted<br>in accordance with the requirements of SMDA 1990 and CFR 807.92 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | 7.2 | Endius, Inc. | |-----------|----------------------| | Submitter | 23 West Bacon Street | | | Plainville, MA 02762 | | 7.3 | Susan Finneran | |---------|-----------------------| | Company | Director RA | | Contact | 508-643-0983 Ext. 114 | | 7.4 | | Proprietary Name: | |--------|--|--------------------------------------------------------------------------| | Device | | Tri-Fix Spinal Fixation System | | Name | | Common Name: | | | | Pedicle Screw System , Non-pedicle spinal fixation system | | | | Classification Name: | | | | Spinal Pedicle Screw (MNI), Spinal Interlaminal fixation orthosis (KWP), | | | | Spondylolithesis Spinal Fixation Device System (MNH) | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K01340 3", with the numbers and letters slightly uneven. Below this, the phrase "page 2 of 3" is written in a similar handwriting style, indicating this is page 2 of a 3-page document. The TrFix Washerless Plate system is intended to be used for posterior lumbar 7.6 fusion procedures. The system is manufactured from titanium which complies Device with ASTM F136. The components, which are included as part of the system, Description include screws, rods, plates, and accessory connection components. #### 7.7 Device Indications and Intended Use The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine. The Tri-Fix Spinal System is a pedicle screw system intended 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and /or sacral screw fixation from T1 to the ilium sacrum. The nonnook, ware, andications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery. #### 7.8 Substantial Equivalence The Washerless Plate with the new nut design is substantially equivalent to the Washerless Plate that was originally cleared via K010903. {2}------------------------------------------------ # (01346) 1/3/3 # 7.10 Summary of Non-Clinical Tests Biomechanical testing according to ASTM F1717 was completed on Washerless Plate constructs with the new nut to demonstrate equivalence to previously cleared components of the TriFix system. Corpectomy constructs were fabricated using Washerless plates (previously cleared) with the new nut (the subject of this 510k) and tested according to ASTM F1717. Both static and fatigue compression tests were completed and the results demonstrated that the new component (nut) is substantially equivalent to previously cleared components of the TriFix system. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### NOV 1 4 2001 Ms. Susan Finneran Director Regulatory Affairs/ Clinical Sciences Endius, Inc. 23 West Bacon Street Plainville, Massachusetts 02762 Re: K013403 Trade Name: Tri-Fix Washerless Plate System Regulatory Class: Class III Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Product Code: MNI, MNH, KWP Dated: October 12, 2001 Received: October 13, 2001 Dear Ms. Finneran: 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. {4}------------------------------------------------ Page 2 - Ms. Susan Finneran 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 nouticate 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (301) 591-1059. Tradition f 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, Mark N Wilkerson elia 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 {5}------------------------------------------------ ## NOV 1 4 2001 510(k) Number (if known): ↑(ひとくろくら K013403 ## Device Name: Tri-Fix Washerless Plate System (Stainless Steel and Titanium) #### Indications for Use: The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back The Trit in Spinal Bj Scent to adisc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine. The Tri-Fix Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the submitsmon of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaluation (ODE) (Posted July 1, 1998) Optional Format 3-10-98) for Mark n Millerson (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K013403 004