Inspections, Compliance, Enforcement, and Criminal Investigations
Amedica Corporation 1/27/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|9200 Corporate Boulevard
Rockville MD 20850
JAN 27 2009
Ashok C. Khandkar, Ph.D.
Chief Executive Officer
615 Arapeen Drive - Suite 302
Salt Lake City, UT 84108
Re: Valeo™-C VBR
Dear Dr. Khandkar:
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) has reviewed various portions of the labeling for the Valeo™-C VBR, which was provided by Amedica Corporation to inspectors from the Denver District Office during an inspection which took place between August 7 and August 20, 2008, and learned that your firm is marketing the Valeo™-C VBR for new intended uses without marketing clearance or approval. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), the Valeo™-C VBR is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that a notice or other information respecting the device for the new uses described below was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81 (a)(3)(ii). Your promotion of the Valeo™-C VBR for intended uses that are not consistent with those cleared in your 510(k) Notifications represents a major change or modification in the intended use that requires the submission of a PMA or a 510(k). For a device requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed satisfied when a premarket approval application (PMA) is pending before the agency, 21 C.F.R. § 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The device was cleared for marketing under premarket notification (510(k)) submission number K073125 and modified under K073505. The cleared Valeo™-C VBR is a trapezoidal spacer with a rectangular inner hole intended to be filled with bone grafting material. It is available in two sizes: small (16 x 12 mm) and medium (17 x 14 mm). The Valeo™-C VBR's height ranges from 5-12 mm. The letters clearing the device for marketing includes the following as part of the Indications for Use Statement:
"The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture)."
The Valeo™ VBR may be used with bone graft.
The intended uses for the Valeo™-C VBR described in the labeling collected by FDA inspectors represent major changes or modifications to the cleared intended uses for this device that could significantly affect its safety or effectiveness. Specifically:
-The Product Specification Sheet provided to FDA inspectors, and also available at http://www.amedicacorp.com/improvement/Valeo-C.html, states that the Valeo™-C VBR "is designed with uoro, a hollow core to accept autograft or biologics." However, the Valeo™-C VBR is cleared for use only with bone graft (i.e., autograft or allograft). It is not cleared for use with biologics.
-Amedica Sales Materials Master Disc - Serial 0001, dated 7-15-2008, includes a video file, "Valeo C CP Surgical Technique _02'08," found in the folder "Sales Material\Training Materials\Videos." The video describes the surgical implantation of the Valeo™-C VBR in the cervical spine along with the Valeo™ CP Cervical Plate System. However, the Valeo™-C VBR is cleared for use only in the thoracolumbar spine, and, according to its indications for use statement the Valeo™ CP Cervical Plate System (K071990) is intended:
". . . for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ CP Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions."
Thus, the Valeo™-C VBR is being marketed and promoted for a use for which it has not been approved or cleared.
It is noted that the information provided in the video file "Valeo C CP Surgical Technique_02'08" is replicated on Amedica Training Course Material Disc, dated 8-18-2008 as "Steps 2-17" in the folder "am cervical 6_aug_08\media."
-The video, "Valeo C CP Surgical Technique_02'08," also clearly describes and depicts an interbody fusion procedure rather than a vertebrectomy or partial vertebrectomy procedure; though the Valeo™-C VBR is cleared for use only in the latter procedures. A vertebrectomy or partial vertebrectomy procedure includes the removal of vertebral bone and placement of the device within the void that is created. The procedure presented in "Valeo C CP Surgical Technique_02'08," however, states: "Perform Discectomy & Decompression with General Instrumentation." The video then shows the removal of disc material and placement of the Valeo™-C VBR device into the intervertebral body space, rather than into a void created by a vertebrectomy of partial vertebrectomy procedure.
OC requests that Amedica Corporation immediately cease the dissemination of promotional materials for Valeo™-C VBR which include the intended uses described above. Please submit a written response to this letter within fifteen (15) working days of receipt of this letter describing your intent to comply with this request, listing all promotional materials for Valeo™-C VBR and explaining your plan for discontinuing use of such materials.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials comply with each applicable requirement of the Act and FDA's implementing regulations.
Failure to promptly correct the promotional violations discussed above may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning letters about devices so that they may take this information into account when considering the award of contracts.
Please direct your response to Dr. Anastacia Bilek at the Food and Drug Administration, 2094 Gaither Road, HFZ-343, Rockville, Maryland 20850, facsimile at (240) 276-0129. We remind you that only written communications are considered official.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
1 The promotion of the use of a biologic material with the Valeo™-C VBR, as described by your promotional material, is of particular concern because of the known serious adverse events associated with the use of biologics (which include, but are not limited to, bone morphogenic proteins (BMPs)) in the cervical spine. On Tuesday, July 1, 2008, FDA issued a Public Health Notification describing life-threatening complications associated with use of BMPs in cervical spine fusion. Note that the safety and effectiveness of BMPs in the cervical spine have not been demonstrated and BMPs are not approved by FDA for this use. FDA's Public Health Notification is available at http://www.fda.gov/cdrh/safety/070108-rhbmp.html.