Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

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September 11, 2020 Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, Georgia 30309 Re: K201506 Trade/Device Name: Talos -C Cervical Intervertebral Body Fusion System, Talos -C (HA) Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 12, 2020 Received: August 13, 2020 Dear Mr. Dunaway: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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. 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Sincerely, Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) ### K201506 ### Device Name Talos®-C Cervical Intervertebral Body Fusion System Talos®-C (HA) Cervical Intervertebral Body Fusion System ### Indications for Use (Describe) Talos®-C Cervical Intervertebral Body Fusion Devices The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Device or anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos@-C Cervical Intervertebral Body Fusion and with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and or craft to faciliate fusion. Non-operative treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation. Talos®-C(HA) Cervical Intervertebral Body Fusion Devices The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fuss are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. Non-operative tratment pror to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) Veeks. Talos®-C(HA) Cervices are to be implemented via an open anterior approach approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperloriotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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To the bottom right of the 'M' is a solid blue circle, completing the logo. # 510(k) Summary As required by section 807.92(c) Meditech Spine, LLC is requesting marketing clearance for the Talos®-C and Talos®-C(HA) Cervical Intervertebral Body System - A. Sponsor/Manufacturer: Meditech Spine, LLC Registration Number: 3009405289 Bruce Dunaway, Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, GA 30309 678-974-5287 Phone 404-759-2104 Fax - Talos®-C Cervical Intervertebral Body Fusion System, Talos®-B. Trade Name: C (HA) Cervical Intervertebral Body Fusion System Common Name: Spinal Implant Intervertebral Body Fusion Device (21 CFR 888.3080 Class II,Product Classification Code ODP) Name: - C. Predicate Device: K150788 (Talos®-C and Talos®-C (HA) Devices) (Primary) K173347 Actilif C FLX (Additional) K163491 CoRoent Small (Additional) ## D. Purpose of Submission: The Purpose of this submission is to expand product offering of the Talos®-C Cervical Intervertebral Body Devices and the Talos®C (HA) Cervical Intervertebral Body Devices to include two additional lordotic angles on all footprints greater than 12mm x 12mm (including the introduction of an 18mm x 15mm footprint). Additionally, the revision of the Indication for Use to expand usage from "one level" to "multiple contiguous levels". - E. Device Description: The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo with a stylized letter 'M'. The 'M' is formed by two rounded shapes, one vertical and one angled, overlapping each other. The vertical shape is a lighter shade of blue, while the angled shape is a darker shade of blue. To the right of the 'M' is a solid dark blue circle, positioned slightly below the center of the 'M'. implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning. The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning. - F. Indication for Use: Talos®-C Cervical Intervertebral Body Fusion Devices The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos® -C Cervical Intervertebral Body Fusion Devices are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous 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 implemented via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic devices (lordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation. Talos®-C (HA) Cervical Intervertebral Body Fusion Devices The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo with a stylized letter "M". The "M" is formed by two overlapping shapes, one in a lighter shade of blue and the other in a darker shade of blue. To the right of the "M" is a solid dark blue circle. The logo has a modern and minimalist design. are intended to be used with supplemental fixation. The Talos-C® (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. Nonoperative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos® C(HA) Cervical IBF Devices are to be implemented via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic devices (lordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation. - G. Technological Characteristics: The following fundamental technological characteristics of the Talos®-C (HA) Cervical IBF Devices are identical to the cleared device: - -Intended Use: See IFU - -Material: PEEK / HA PEEK - -Implant Markers: Tantalum / Titanium - -Design: Rectangular, teeth on inferior and superior surfaces, insertion feature - -Sterilization / Packaging: Gamma - -Instrumentation: See Surgical Technique - H. Non-clinical Testing: Testing according to ASTM F2077-11 and ASTM 2267-04 was performed on the previously cleared Talos®-C and Talos®-C (HA) Cervical IBF Devices. The tests included static compression, compression shear and torsion tests, dynamic compression shear and torsion tests, as well as subsidence testing bending. Finite Element Analysis and engineering analysis were performed on the subject devices to confirm that a new worst-case is not presented in the proposed devices. Talos®-C and Talos®-C (HA) Cervical IBF Devices are superior in mechanical function and properties to the cleared device. - I. Conclusion: The identical intended use and consistency between the fundamental scientific technology between the Talos®-C and Talos®-C (HA) Cervical IBF Devices allows that both are substantially equivalent to the cleared device.