(297 days)
When used as an intervertebral body fusion device, the Seaser System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.
When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.
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This document is a 510(k) premarket notification decision letter from the FDA for the SeaSpine Spacer System - Hollywood NM (Nanometalene). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document primarily focuses on the FDA's determination of substantial equivalence to predicate devices and outlines general regulatory requirements for the manufacturer.
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§ 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.