ENDIUS CERVICAL PLATE SYSTEM

{0}------------------------------------------------ K014107 1/3 ## FEB 1 3 2002 # Section 7 - 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted 7.1 in accordance with the requirements of SMDA 1990 and CFR 807.92 Statement | 7.2 | Endius, Inc. | |-----------|----------------------| | Submitter | 23 West Bacon Street | | | Plainville, MA 02762 | | 7.3 | Gene DiPoto | | |---------|-----------------------|--| | Company | VP of Engineering | | | Contact | 508-643-0983 ext. 104 | | | 7.4 | Proprietary Name: | Endius Cervical Plate System | |-------------|----------------------|----------------------------------------------------| | Device Name | Common Name: | Anterior Cervical Plating System | | | Classification Name: | Spinal Intervertebral Body Fixation Orthosis.(KWQ) | | 7.5 | | |---------------------|-----------------------------------------------------------------------------| | Predicate | The Endius Cervical Plate System is substantially equivalent to the Window | | Legally | Dynamic Plate System Plate System manufactured by Endius, Inc. (Plainville, | | Marketed<br>Devices | MA.) | {1}------------------------------------------------ # K014107 2/3 7.6 The Endius Cervical Plate System is a set of implants designed to be implanted Device via an anterior approach to the cervical spine. The system includes various Description plates and screws manufactured from Titanium. The material used in the manufacture of the components in the Endius Cervical System meets ASTM F136 for Ti 6A1-4VELI. #### 7.7 The Endius Cervical Plate System is intended for anterior interbody screw Device fixation of the cervical spine. The system is indicated for use in the Indications and temporary stabilization of the anterior spine during the development of Intended use cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine 7.8 The Endius Cervical Plate System is substantially equivalent to the Window Substantial Cervical Spinal System. Equivalence Following is a table that describes the features of the new and the predicate systems that indicate substantial equivalence. Testing was also completed as per ASTM F1717 in order to demonstrate equivalence. {2}------------------------------------------------ ### 3/3 K014107 | Device Name | The Endius Cervical Plate<br>System | Window Cervical System | |-----------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Product<br>Components | Plates of various lengths, 4mm<br>screws, 4.3mm revision screws | Identical components with identical<br>specifications | | Indications for Use | See above | Identical | | Materials | Titanium | Titanium | | Product Labeling | Instructions for use and box<br>labeling including all of the<br>necessary warning statements | Instructions for use and box labeling<br>including all of the necessary<br>warning statements | | Packaging/<br>Sterilization | Non-sterile, single use only | Non-sterile, single use only | | Biomechanical<br>Testing | Meets ASTM F1717 | Meets ASTM F1717 | ## 7.9 Table of Substantial Equivalence Applicant Geen Diloh Date 12/12/01 112 :- --- , --- {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three horizontal lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 3 2002 Mr. Gene DiPoto Vice President of Engineering Endius Incorporated 23 West Bacon Street Plainville, Massachusetts 02762 K014107 Re: > Trade Name: Endius Cervical Plate System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: December 12, 2001 Received: December 13, 2001 Dear Mr. DiPoto: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 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); 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. {4}------------------------------------------------ Page 2 - Mr. Gene DiPoto This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Miriam C. Provost for Celia 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}------------------------------------------------ 510(k) Number (if known): K014107 Device Name: Endius Cervical Plate System ### Indications for Use: The Endius Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. (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) Miriam C. Provost Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_KO14107 3