(272 days)
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.
The provided text is a 510(k) summary for the ORIA Spinal Clip System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, primarily through comparison of indications for use, anatomic sites, design, materials, and function, rather than through performance metrics for an AI algorithm.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.