(114 days)
The ELITE™ IBF Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-S1. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.
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The provided text is a Premarket Notification (510(k)) letter from the FDA regarding the ELITE™ IBF Expandable Lumbar Fusion System. This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. It is a regulatory clearance document, not a clinical study report. Therefore, I cannot extract the requested information from this 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.