NuVasive‘g'i Incorporated
`
`FEB " 7
`
`700“;
`
`5 l0(k) Premarket Notification
`CoRoentTMSvstem
`
`# V
`
`II. 510(k) Summary
`
`K04 3H05
`P439 l 0‘? Z
`
`In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of
`Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of
`safety and effectiveness information is provided:
`
`.4. Submitted by
`
`Laetitia Cousin
`Director of Regulatory Affairs and Quality Assurance
`NuVasive, Incorporated
`4545 Towne Centre Court
`
`San Diego, CA 92121
`Telephone: (858) 909—1868
`Date Prepared: February 1, 2005.
`
`B. Device Name
`
`Trade or Proprietary Name:
`Common or Usual Name:
`Classification Name:
`
`Nu Vasi vs CoRoenl System
`Vertebral Body Replacement Device
`Vertebral Body Replacement Device
`
`C. Predicate Devices
`
`The subject device is substantially equivalent to similar previously cleared devices.
`
`D. Device Description
`
`The NuVasive CoRoent System is an implantable PEEK vertebral body replacement
`device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a
`diseased vertebral body resected or excised for the treatment of a collapsed, damaged,
`or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of
`the spinal cord and neural tissues.
`
`The device is available in a variety of different shapes and sizes to suit the individual
`pathology and anatomical conditions of the patient.
`
`MSD 1 143
`|PR2013-00506
`
`|PR2013-00508
`
`

`

`
`
`510(k) Premarket Notification
`NuVasive‘R‘. Incorporated
`CoRoenITM System
`
`
`W K
`
`E. Intended Use
`
`O ‘43 L} 05’
`Pvt” z 0% z
`
`The NuVasive CoRoent System is a partial vertebral body replacement device indicated for
`use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or
`excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor
`or trauma and to achieve decompression of the spinal cord and neural tissues. The System is
`intended to be used with supplemental internal spinal fixation systems that are cleared by the
`FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at
`the surgeon’s discretion.
`
`F. Comparison to Predicate Devices
`
`As was established in this submission, the subject device is substantially equivalent to the
`
`following predicate devices:
`
`K0335 l7
`
`Spinal Concepts CadenceTM Spinal concepts, Inc.
`
`K01 l037
`
`Vettebral Spacer
`
`Synthes
`
`K032476
`
`NuVasive Mesh
`
`NuVasive, lnc.
`
`K04 1939
`
`Blackstone VBR System
`
`Blackstone Medical, Inc.
`
`Engineering drawings, labeling, and mechanical testing have demonstrated that the subject
`device is substantially equivalent, if not identical, to its predicate devices in terms of design,
`materials of composition, indications for use, and such other characteristics as may be
`associated with the manufacture of any medical device.
`
`G. Summary of Non-Clinical Tests
`
`Mechanical testing was presented.
`
`H. Summary of Clinical Tests
`
`(Not Applicable).
`
`

`

`W.
`‘V
`
`9
`
`i. g. DEPARTMENTOFHEALTH8?.HUMANSERVICES
`
`
`
`PublicHealthService
`
`Food and Drug Administration
`9200 Corporate Boulevard
`Rockville MD 20850
`
`'_
`(EB
`
`_
`
`-
`7 2005
`
`Ms. Laetitia Cousin
`Director of Regulatory Affairs and Quality Assurance
`NuVasive, Inc.
`4545 Towne Centre Court
`
`San Diego, California 92121
`
`Re: K043405
`
`Trade/Device Name: NuVasive CoRoent System
`Regulation Number: 21 CFR 888.3060
`Regulation Name: Spinal intervertebral body fixation orthosis
`Regulatory Class:
`11
`Product Code: MQP
`Dated: December 9, 2004
`
`Received: December 10, 2004
`
`Dear Ms. Cousin:
`
`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 11 (Special Controls) or class ill (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 ofthe Act); 21 CFR 1000~ 1050.
`
`
`
`

`

`Page 2 — Ms. Laetitia Cousin
`
`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), please
`contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled,
`“Misbranding by reference to premarket notification” (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://wwwfda.gov/cdrh/industry/supmrt/indexhtml.
`
`Sincerely yours,
`
`all «WW
`
`“Celia M. Witten, Ph.D., MD.
`‘ Director
`
`‘
`
`Division of General, Restorative
`
`and Neurological Devices
`Office of Device Evaluation
`
`Center for Devices and
`
`Radiological Health
`
`Enclosure
`
`
`
`

`

`CoRoemTM System
`NuVasive®, Incorporated
`WW
`
`510(k) Premarket Notification
`
`V. Draft Labeling
`
`A. Indications for Use
`
`510(k) Number (if known):
`
`K0 Ll :3 H05
`
`Device Name: NuVasive Congm System
`
`Indications for Use:
`
`The NuVasive CoRoent System is a partial vertebral body replacement device indicated for
`use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or
`excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to
`tumor or trauma and to achieve decompression of the Spinal cord and neural tissues. The
`System is intended to be used with supplemental internal spinal fixation systems that are
`cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material
`may be used at the surgeon’s discretion.
`
`W
`
`.
`A (Division Sigma)
`Divisioa at General, Restorative,
`and Neurological Devices
`
`
`
`510(k) Number KW 3 /0(
`
`6
`
`X
`Prescription Use
`(Part 21 CFR 801 Subpart D)
`
`AND/OR
`
`Over—The—Counter Use
`(2i CFR 807 Subpart C)
`
`(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF
`NEEDED)
`
`
`Concurreuce of CDRH, Office of Device Evaluation (ODE)
`
`
`
`

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