(378 days)
The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P is composed of a PEEK (ASTM F2026) spacer with a radiopaque marker (ASTM F136-2a), a titanium alloy anterior plate and screws (ASTM F F1295). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism. The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions. This line extension covers the addition of sterile screws.
The provided text is a 510(k) summary for the Synthes Zero-P, an intervertebral fusion device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets them. Instead, it explicitly states:
"Mechanical and clinical data and conclusions were not needed for this device. The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate."
Therefore, based on the provided document, I cannot fulfill the request as it asks for information that is not present. The document indicates that a study for acceptance criteria was not required for this specific filing.
§ 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.