(72 days)
When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.
The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. The bone contacting surfaces of the implants have machined teeth which are designed to engage with the vertebral body endplates. Tantalum markers are embedded within the spacers identify the location and orientation of the implants to radiographically. Implants with footprints ranging from 24x30mm-28x36mm are available to accommodate anatomical variations. The purpose of this submission is to add 30x40mm footprints to the system.
The provided text describes a 510(k) summary for the Chesapeake Spinal System, an intervertebral body fusion device. While it details the device's description, intended use, materials, and substantial equivalence to predicate devices, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria.
The document is a regulatory submission demonstrating substantial equivalence to existing legally marketed devices, rather than a report on a clinical or performance study with defined acceptance criteria and results.
Therefore, I cannot provide the requested information based on the input text. The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use, rather than requiring new clinical performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission might.
§ 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.