(27 days)
The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.
Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.
The PATHWAY device can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.
The proposed modification to the PATHWAY Intervertebral Body Fusion Devices (PLIF and TLIF) is to The proposed mountedion with the currently cleared titanium (Ti-6Al-4V) markers.
The provided text is a 510(k) summary for a medical device called "PATHWAY Intervertebral Body Fusion Device." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.
The document explicitly states: "Performance Data was originally performed on the PATHWAY Device (K080281). The proposed changes do not impact the mechanical performance of the device." This indicates that the current submission (K111774) is for a modification that does not require new performance data or a new study, but rather relies on the performance data of the previously cleared predicate device (K080281).
Therefore, I cannot provide the requested information from the given 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.