(25 days)
The CerviFix® System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- Tumors
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
Synthes CerviFix® consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or titanium alloy.
The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.
I am sorry, but the provided text describes a medical device (Synthes CerviFix® System and its accessories) and its indications for use, along with FDA regulatory information (510(k) premarket notification).
However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study proving the device meets acceptance criteria. It is purely a description of the device and its regulatory clearance process.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.