TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES

K122850 · Meditech Advisors, LLC · ODP · Mar 28, 2013 · Orthopedic

Device Facts

• Record ID: K122850
• Device Name: TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
• Applicant: Meditech Advisors, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Mar 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion, Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.

Device Story

Talos®-C Cervical Intervertebral Body Fusion Device; intervertebral body fusion implant; used in cervical spine (C2-T1) for degenerative disc disease. Implanted via open anterior approach by surgeons; requires supplemental fixation and autologous bone graft to facilitate fusion. Device provides structural support to vertebral space; promotes spinal fusion; relieves nerve root/spinal cord compression. Benefits patients by stabilizing spinal segment; reducing symptoms of radiculopathy/myelopathy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intervertebral body fusion device; intended for cervical spine; requires supplemental fixation and autologous bone graft; open anterior surgical implantation.

Indications for Use

Indicated for skeletally mature patients with cervical Degenerative Disc Disease (DDD) at one level from C2-T1, presenting with intractable radiculopathy and/or myelopathy due to herniated disc or osteophyte formation causing nerve root/spinal cord compression. Requires 6 weeks of failed non-operative treatment. Must be used with autologous bone graft and supplemental fixation via open anterior approach.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2013

Meditech Advisors, LLC % MEDIcept, Inc. Dr. Sharyn Orton 200 Homer Avenue Ashland, Massachusetts 01721

Re: K122850

Trade/Device Name: Talos®-C Cervical Intervertebral Body Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 04, 2013 Received: February 26, 2013

Dear Dr. Orton:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Dr. Sharyn Orton

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# meditech advisors, IIc.

878 Briarcliff Road, Suite A-2 Atlanta, GA 30306 | p [phone] | f [phone] | [e-mail]

# Indications for Use Form

#### 510(k) Number: K122850

Device Name: Talos®-C Cervical Intervertebral Body Fusion Devices

# Indications for Use:

The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion,

Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.

Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use 21CFR 801.109

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev. PhD Division of Orthopedic Devices