(54 days)
The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
The TotalTi ACDF by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The TotalTi ACDF by SAGICO, is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are customizable additively manufactured and available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The TotalTi ACDF by SAGICO, incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The TotalTi ACDF by SAGICO implant requires the internal fixation blades to be deployed and is designed to be used with FDA cleared supplemental fixation to properly utilize the device. The TotalTi ACDF by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.
MATERIALS: The TotalTi ACDF by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The TotalTi ACDF by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001and traditionally machined titanium alloy anchors lock per ASTM F136.
FUNCTION: The TotalTi ACDF by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical region.
This is a medical device 510(k) summary for the TotalTi ACDF by SAGICO, an intervertebral body fusion device. The document describes the device, its indications for use, and non-clinical performance data. Since this is a submission for an intervertebral body fusion device and not an AI/ML powered device, the provided document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as these are typically associated with performance studies for AI/ML devices. As a result, I cannot provide an answer based on the provided text.
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.