ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR

{0}------------------------------------------------ # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Date Prepared: . November 29, 2010 ### Submitter Information: | Submitter's Name: | Apollo Spine | |--------------------|------------------------------------------------------| | Address: | 3700 Campus Dr. Suite 105<br>Newport Beach, CA 92660 | | Telephone: | 949-645-1615 | | Fax: | | | Contact Person: | Christine Santagate, STD Medical | | Telephone : | 781-828-4400 | | Fax : | 781-344-5895 | | Device Trade Name: | Eclipse Vertebral Spacer-Lumbar | | Common/Usual Name: | Intervertebral body fusion device | | Classification: | 21 CFR §888.3080 | | Class: | II | | Product Code: | MAX, MQP | #### Intended Use: When used as an Intervertebral Body Fusion System: The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required. When used as a Vertebral Body Replacement Device: The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from . K102121 Page 1 of 2 {1}------------------------------------------------ TI-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required. # Device Description and Technological Characteristics: The Eclipse Vertebral Spacer-Lumbar acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. The device contains serrations on the superior and inferior surfaces and includes positioning pins that are advanced during placement. Pins are used to aid in the positioning and to allow for radiographic confirmation during device placement. #### Predicate Device(s): The Eclipse Vertebral Spacer-Lumbar was shown to be substantially equivalent to previously cleared devices and had the same indications for use, design, materials, and performance. # Nonclinical Testing Summary and Conclusion: The substantial equivalence is supported by nonclinical bench testing. Tests were selected in accordance with those described in FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." The specific testing completed is detailed as follows: - Static Compression (per ASTM 2077) � - Dynamic Compression (per ASTM 2077) - Static Compression Shear (per ASTM 2077) ● - Dynamic Compression Shear (per ASTM 2077) ● - t Subsidence (per ASTM 2267) - . Analysis of wear debris generated during dynamic testing Test results for each of the above studies confirm that the Eclipse Vertebral Spacer is substantially equivalent to the predicate devices {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with flowing lines beneath them, resembling a flag or banner. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Apollo Spine % STD Medical, Inc. Ms. Christine Santagate 3700 Campus Drive, Suite 105 Newport Beach, California 92660 SEP 12 100 Re: K102121 Trade/Device Name: Eclipse Vertebral Spacer System-Lumbar Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II > Product Code: OVD, MQP Dated: December 14, 2010 Received: December 20, 2010 Dear Ms. Santagate: This letter corrects our substantially equivalent letter of January 12, 2011. 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 (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 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 {3}------------------------------------------------ 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/ReportaProblem/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 vours. Sincerely yours, Mark A. Milken Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): K 102121 Device Name: Eclipse Vertebral Spacer System-Lumbar # JAN 1 2 2011 When used as an Intervertebral Body Fusion System: The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required. When used as a Vertebral Body Replacement Device: The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from TI-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 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 Surgical, Orinopedic, and Restorative Devices KID2121 510(k) Number_