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`Synthes Spine 51 O(k) Premarket Notification Vertebral Spacer
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`3.0 Summary of Safety and Effectiveness Information
`
`SPONSOR:
`
`Synthes (USA)
`1690 Russell Road
`Paoli, PA 19301
`(61 0) 647-9700
`Contact: Jonathan Gilbert
`
`DEVICE NAME:
`
`Vertebral Spacer
`
`CLASS1 FICATION:
`
`PREDICATE DEVICE:
`
`DEVICE
`DESCRIPTION:
`
`. -
`
`The classification of the Vertebral Spacer components is Class
`II, as per the Code of Federal Regulations, Title 21, Section
`888.3060: Implant, fixation, spinal intervertebral body fixation
`orthosis devices. The product code is MBp. The Panel code
`is 87.
`DePuy-AcroMed Stackable Cage System - KO01 340
`
`The Synthes Vertebral Spacer is a radiolucent vertebral body
`replacement device used in conjunction with supplemental
`internal fixation to provide structural stability in skeletally
`mature individuals following corpectomy.
`
`The design of the Vertebral Spacer includes rectangular,
`stackable components of different cross-sectional sizes and
`height, bolts and a nut. The rectangular stackable components
`are available in four footprints and three heights to suit the
`individual pathology and anatomical conditions of the patient.
`
`A Vertebral Spacer may be used individually, or two or more
`may be stacked together to accommodate the anatomical
`requirements of
`the vertebral space created by
`the
`corpectomy. When stacked, a bolt is inserted through the
`stackable components. A nut is then attached to the bolt to
`compress the stackable components together to create a rigid
`construct. The superior and inferior surfaces of the implants
`have ridges which engage between stacked implants and
`interface with the vertebral endplates.
`
`The interior of the spacer is open and can be packed with bone
`graft. The implant is always implanted in the vertical position
`and the surgeon should select the largest footprint that will fill
`the void created by the tissue resection.
`
`

`
`INTENDED USE:
`
`Synthes Spine 51 O(k) Premarket Notification Vertebral Spacer
`K O \ i o 3 7
`pwj" 2 04%
`The Vertebral Spacer is a vertebral body replacement device
`intended for use in the thoracolumbar spine (T1 -L5) to replace
`a collapsed, damaged, or unstable vertebral body due to tumor
`or trauma (i.e., fracture). The Vertebral Spacer is intended to
`be used with Synthes supplemental internal fixation systems,
`e.g., ATLP, VentroFix and USS. The interior of the spacer
`component of the Vertebral Spacer system can be packed with
`bone.
`
`MATERIAL:
`
`PERFORMANCE
`DATA:
`
`BASIS OF
`SUBSTANTIAL
`EQUIVALENCE:
`
`The Vertebral Spacer is designed to provide anterior spinal
`column support even in the absence of fusion for a prolonged
`period.
`
`(PEEK3
`Radiolucent polymer and titanium alloy (nut and bolt) materials
`in conformance with ASTM Standard Specifications.
`
`Mechanical and Chemical information were presented.
`
`The Synthes Vertebral Spacer implants are similar to the
`components of a previously cleared spinal system (KO01 340).
`The Vertebral Spacer material is comprised of polymer and
`contains no carbon fiber. The supplemental fixation devices
`intended for use with the Vertebral Spacer are currently
`cleared for patients with either tumor or fractures.
`
`

`
`DEPARTMENT OF HEALTH &HUMAN SERVICES
`
`Pubiic Health Service
`
`.
`
`.
`
`
`
`’ . . Food and Drub Administration
`,9200 Corporate Boulevard
`Rockville MD 20850
`
`Mr. Jonathan Gilbert
`Project Manager, Regulatory Affairs
`Synthes (USA)
`1690 Russell Road
`Paoli, PA 19301
`
`Re: KO11037
`TradeDevice Name: Vertebral Spacer
`Regulation Number: 21 CFR 888.3060
`Regulation Name: Spinal intervertebral body fixation orthosis
`Regulatory Class: Class I1
`Product Code: MQP
`Dated: April 19,2002
`Received: April 22,2002
`
`Dear Mr. Gilbert:
`
`We have reviewed your Section 5 1O(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 I1 (Special Controls) or class I11 (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 (2 1
`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 53 1-542 of the Act); 21 CFR 1000-1050.
`
`

`
`’ Page 2 - Mr. Jonathan Gilbert
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`. . .
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`-
`
`This letter will allow, you to begin marketing your device as described in your Section 5 1 O(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.
`
`.
`
`.
`
`.*?.+A:.
`
`, .,‘L,
`
`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” (2 1 CFR 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,
`
`Director
`Division of General, Restorative
`and Neurological Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`

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`Synthes Spine 51 O(k) 'Premarket Notification Vertebral Spacer
`
`2.0
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`Indications for Use Statement
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`.
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`' 510(k) Number (if known):
`Device Name:
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`Indications:
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`kb (l.0 31
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`. Page 1 of 1 ,
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`Vertebral Spacer
`
`The Vertebral Spacer is a vertebral body replacement device intended for use in the
`thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral
`body due to tumor or trauma (i.e., fracture). The Vertebral Spacer is intended to be
`used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and
`USS. The interior of the spacer component of the Vertebral Spacer system can be
`packed with bone.
`
`The Vertebral Spacer is designed to provide anterior spinal column support even in the
`absence of fusion for a prolonged period.
`
`(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
`NEEDED)
`
`,
`
`Concurrence of CDRH, Office of Device Evaluation (ODE)
`
`Prescription Use J OR
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`(Per 21 CFR 801 .log)
`
`Over-The-Counter Use-