Spinal Elements, Inc 6/12/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
June 12, 2014
Jason D. Blain
Spinal Elements, Inc.
3115 Melrose Drive
Carlsbad, California 92010
Dear Mr. Blain:
During an inspection of your firm located in Carlsbad, California on January 6 through January 15, 2014, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Lucent and Lucent Ti-Bond Intervertebral Body Fusion Devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Our inspection revealed that the Lucent and Lucent Ti-Bond Intervertebral Body Fusion Devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Specifically, the Lucent and Lucent Ti-Bond Intervertebral Body Fusion Devices were cleared via K071724 and K110632, respectively. These 510(k)s were cleared for straight and curved designs of various sizes. The current inspection revealed that in (b)(4) you have added a line of “bulleted” design to the Lucent and Lucent Ti-Bond devices where there were overall (b)(4) changes that may impact the mechanical strength of the implants. With the implementation of the “bulleted” design, you have also added (b)(4) sizes (10x27mm & 10x32mm) and implemented a 5o lordosis angle to (b)(4) sizes (10x22 mm, 10x27mm, 10x32mm & 12x27mm).
Your addition of the bulleted design is a major design change from your original premarket clearance submission that can significantly affect the safety and effectiveness of the device, and thus requires a new 510(k).
Your devices are further adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B) and misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), due to unsubstantiated claims made in your labeling and website regarding the Ti-Bond coating. Such claims include the following:
- “The radiolucency, elastic modulus, and strength of PEEK join the benefits of micro-textured titanium, an osteophilic surface that stimulates osteogenic factors.”
- “Spinal Elements’ Ti-Bond titanium porous coating, combined with the outstanding clinical history of our Lucent PEEK interbody implants, creates the ideal environment for bone healing during fusion.”
- “Osteogenic potential”
- “Scratch-fit implantation against the vertebral endplates results in immediate initial stability. Implant insertion seeds the titanium surface pores with bone, blood, and cells, supporting the osteoconduction and osteoinduction necessary for long-term fixation.”
- “Recruits pluri-potential osteogenic cells”
- “Minimize implant migration”
- “Random, unconnected pores create an ideal bone-apposing surface for peri-implant bone growth.”
- “During implantation, the Ti-Bond surface scratches the vertebral endplates, leading to initial stability, long-term fixation, and the integration of osteocytes.”
- “The porous titanium and increased surface area of bony contact stimulate the proliferation of osteoblasts.”
- “The roughened titanium surface creates a scratch-fit that increases initial and long term stability.”
- “The bioactive properties of roughened titanium are well-understood and known to increase osteogenic potential at the point of bony contact.”
- “Porous titanium and increased surface area of bony contact have been shown to stimulate the proliferation of osteoblasts and the integration of osteocytes.”
In addition, device labeling (1) Surface Matters – Histology and Push-Out Strength Data at Four Weeks and (2) Surface Matters – 5X Stronger Push-Out Resistance at Four Weeks, include a performance claim regarding resistance of Ti-Bond coated cages to expulsion forces (“5x stronger push-out resistance at four weeks”), along with histologic images and a bar chart. There is a link to a summary report of an evaluation of Ti-Bond vs. PEEK fixation in a sheep model; however, this information has not been reviewed, nor was this presented in the original clearance.
Please note that during review of the titanium-coated PEEK devices (K110632), your firm was specifically asked the following in (b)(4) dated (b)(4):
Your response to this query, dated (b)(4), is as follows:
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your reply should be sent to the following address:
Mr. Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, CA 92612-2506
If you have questions regarding this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477. Include CMS #421804 when replying to this letter.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence