GRAFTCAGE TLX

{0}------------------------------------------------ ## KOS 1781 1 2 # DEC 16 2005 510(k) Summary GraftCage™ TLX | Submitted by | Address | Telephone | Contact Person | |---------------------|------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Osteotech, Inc. | 51 James Way<br>Eatontown, New Jersey<br>07724 | (800) 537-9842<br>x 6324 | Christopher Talbot<br>Dir. Regulatory Affairs | | DATE June 20, 2005 | Subject Device | | Predicate Devices | | Trade Name | GraftCage TLX | | • Synthes Spine's Vertebral Spacer-TR,<br>K011037, cleared July 1, 2002;<br>• Interpore Cross's GEO Structure,<br>K010530, cleared August 3, 2001; and<br>• Stryker Spine's AVS TL Spacer,<br>K042571 cleared February 11, 2005. | | Common Name | Vertebral Body Replacement Device | | | | Classification Name | Spinal Intervertebral Body Fixation Orthosis | | | #### Device Description: The GraftCage TLX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in cases of spinal trauma/fracture. The GraftCage TLX is made from implantable PEEK (polyetheretherketone) polymer. The GraftCage TLX is rectangular -to- oval in shape, with its anterior aspect slightly convex and posterior aspect slight concave. One central (axial) fenestration and two fenestrations on each anterior and posterior aspect provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and /or migration after implantation. The device is nonlordotic (0°) i.e., parallel. The lateral aspects are tapered, or bulleted, for ease of insertion. Two threaded holes, one at each lateral aspect, interface with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches both threaded holes on the GraftCage TLX and allows the surgeon to hold the GraftCage TLX while implanting it into the patient. Each threaded hole is at a different angle relative to the long axis of the implant. The different angles allow the surgeon to choose the best surgical approach depending upon the specific clinical situation. #### Intended Use: The GraftCage™ TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (T1-L5). The GraftCage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional. {1}------------------------------------------------ 510(k) Summary GraftCage TLX Osteotech, Inc. #### Comparison to Predicate: The GraftCage TLX claims substantial equivalence to: 1) Synthes Spine's Vertebral Spacer-TR, K011037, cleared July 1, 2002; - 1) Synthes Spine 3 V GEO Structure, K010530 cleared August 3, 2001; and - 2) Stryker Spine's AVS TL Spacer, K042571 cleared February 11, 2005. This claim of substantial equivalence is intended to reflect FDA's definition of substantial equivalence as defined by 21 CFR Part 807, Subpart E and is not intended to reflect a claim of substantial equivalence in terms of intellectual property. The GraftCage TLX and the predicate devices have the same intended use and similar technological The GraftCage TLX and the produced deverates that the GraftCage TLX meets or exceeds functional requirements for a vertebral body replacement device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three figures in profile, representing health and human services. Public Health Service DEC 16 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Christopher Talbot Director, Regulatory Affairs Osteotech Incorporated 51 James Way Eatontown, New Jersey 07724 Re: K051781 Trade Name: GraftCage™ TLX VBR System Trade Name: Sierrer: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 8, 2005 Received: December 9, 2005 Dear Mr. Talbot: We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced We have reviewed your Section 10(c) prematically equivalent (for the indications for use stated in the above and have devels is device is substantially to the normance prior to May 28, 1976, enclosure) to legally marketed in interstate on interste commerce prior to May 28, 197 enclosure) to legally marketed predicate devices markets, or to devices that have been reclassified in the enactment date of the Medical Device Amendments, or to devices that the enactment date of the Medicel Device Amending of to device the for that do not require accordance with the provisions of the Federal Food, Drug, and Cosmetice, market the accordance with the provisions of the Federal Production, make the device, subject to approval of a premarket approval application (PMA). You may, the Act include approval of a provisions of the Act. The general controls provisions of the Act include the general controls provisions of the Act. The general controls provisions of the Ac the general controls provisions of the Act. I ne gelievis provises, good manufacturing practice, labeling, and requirements for annual registration, listing of devices, good requirements for annual varies and adulteration. ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be found in the If your device is classified (see above) into either class ut (Special Conne very of the vise can be found in the subject to such additional controls. Extraig major regalitions atiooning Code of Federal Regulations, Title 2 i, Parts 80 to 898. In addition, FDA may publish further Cod Code of Federal Regulations, The Vice in the Federal Register. Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that Please be advised that FDA 's issuance of a substantal equirements of the Act or any FDA has made a determination that your device comples with ather requirements of the all FDA has made a determination that your device compites You must comply with all the Federal statutes and regulations administed or registration and listing (21 CFR Part 807); abeling (21 Act's requirements, including, but not limite are wirements as set fort Act's requirements, including, but not himied to ricense as set forth in the quality systems (QS) CFR Part 801); good manufacturing practice requirements as set forth in the CFR Part 801); good manufacturing practice requirents as set rother from the provisions regulation (21 CFR Part 820); and if applicable, the electronic product radiation cont (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 – Mr. Christopher Talbot This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I his letter will allow you to begin marketing your device to a legally market predicate notification. The FDA Inding of substancial equivals. So your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact (1) idease contact (1) idease contact (1) idease contact (1) idease If you desire specific advice for your de 160 en barness and e the regulation entitled, "Misbranding by the Office of Compliance at (240) 276 0126. Thiss) press are may obtain other general information on reference to premiation (21 ct readon' (21 ct read Manufacturers, International and your responsibilities under the Rection the Drivision of Call or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT # 510(k) NUMBER (IF KNOWN): K OS 1 7 81 ## DEVICE NAME: GraftCage TLX ## INDICATIONS FOR USE: The GraftCage™ TLX is a vertebral body replacement device intended to replace a The Grantcage - TEA Is a vertebral body in the thoracic or lumbar spine (TI-L5). conapsed, uainaged, or unsacted for a partial or total vertebrectomy for cases of tumor or The Grancage TLX is marcated for a particage TLX is intended to achieve anterior decompression trauma (f.c., fractare). "The Crasveal and to restore the height of a collapsed vertebral body. The GraftCage TLX is intended for use with supplemental internal spinal fixation The Grancage TEA is meended for use in the thoracic and lumbar spine. These systems Systems that are created of rear and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional. Prescription Use_V (Per 21 CFR 801.109) OR Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________ X_____________________________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use (Part 21 CFR 801 Subpart D) 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 General, Restorative, | | and Neurological Devices | | 510(k) Number | K051781 | |---------------|---------| |---------------|---------|