(97 days)
The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion System is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Ali Interbody Fusion System is used to provide structural stability and maintain disc space distraction during intervertebral body fusion in the lumbosacral spine. The Subject Device implants are fabricated from PEEK (ASTM F2026) with Titanium endplates (ASTM F136). The Ali Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage assembly has a hollow center to allow placement of autograft and/or allograft. Fixation ridges on the superior and inferior endplates of the device help to grip the endplates and prevent expulsion.
This FDA 510(k) summary describes a spinal interbody fusion device, not a medical device software or AI algorithm. Therefore, the provided text does not contain information related to acceptance criteria, a study proving an AI device meets those criteria, or details regarding ground truth, expert adjudication, or MRMC studies.
The document discusses the substantial equivalence of the Ali Interbody Fusion System (a physical medical device) to legally marketed predicate devices, based on:
- Indications for Use: Intervertebral body spinal fusion procedures for degenerative disc disease and degenerative scoliosis.
- Technological Characteristics: Made from PEEK and Titanium, with specific design features for stability and bone graft placement.
- Performance Testing: Non-clinical mechanical testing (Static and Dynamic Compression and Shear, Subsidence, and Expulsion) to demonstrate substantial equivalence to predicate devices.
Therefore, I cannot extract the information required by your prompt, as it is designed for AI/software-based medical devices, and the provided text is for a physical orthopedic implant.
§ 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.