(220 days)
The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment of a solid spinal fusion. Except for situations using pedients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (15-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scollosis, kyphosis, and lordosis
- Fracture
- Unsuccessful provious attempts at spinal fusion
- Tumor resection
The CD HORIZON" Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON" Spinal System is limited to non-cervicel use. The CD HORIZON" Screws, TSRH" Variable Angle Screws, LIBERTY" screws, and/or DYNA-LOK" bolts, when used as pedicle screws with the CD HORIZON" Spinal System, is intended only for patients: (a) having severe spondylojisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vartebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than 13 and not lower than the sacrum. Otherwise the CD HORIZON" screws, TSRH Variable Angle Screws, LIBERTY" screws, and/or DYNA-LOK" bolts, when used with the CD HORIZON" Spinal System, are intended for sacraliliac attachment only. The CGD™ Screw for Sacral Block and CCD™ Conical Fixation Screws are intended for sacraliliac attachment only. All of the CD HORIZON® hooks are intended for thoracic and/or lumbar attachment only. GDLH" CROSSLINK" Bars, CD HORIZON" Low Profile CROSSLINK" plates, and TSRH" CROSSLINK" plates are intended for posterior thoracic, lumbar, and/or sacral use only.
The CD HORIZON" Spinal System is a spinal rod based system. The CD HORIZON" implant components, as well as the stainless steel implant components from the systems, can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case. Implant compising the CD HORIZON" and those components from other stainless steel Sofanor Danek spinal systems which the CD HORIZON" Spinal System are listed in the following table.
This document is a 510(k) summary for the CD HORIZON™ Spinal System, a medical device for spinal fixation. It describes the device components, indications for use, and a statement about mechanical test data.
Crucially, this document is from a premarket notification (510(k)) submitted in 1996 for a spinal implant system. It describes the device itself and its equivalence to other commercially available devices. It does NOT contain information about acceptance criteria or a study proving that an AI-powered device meets acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device's performance based on the provided text. The document pertains to a physical spinal implant, not an AI or software device, and does not discuss any performance metrics or studies in the context of an AI system.
§ 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.