(8 days)
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating 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 and 4.0 mm cancellous, 3.5 mm cortex, 4.0mm and 4.35 expansionhead) 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.
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.
Synthes CerviFix System consists of rods, plate/rods, clamps, screws and nuts. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).
This document is a 510(k) summary for the Synthes CerviFix System, a medical device intended to promote fusion of the cervical spine and occipitocervical junction. The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details typically associated with studies proving device effectiveness as requested.
Instead, it focuses on:
- Device Description: The components and materials of the Synthes CerviFix System.
- Indications for Use: The specific medical conditions for which the device is intended.
- Regulatory Information: A letter from the FDA confirming substantial equivalence to pre-amendment devices and outlining regulatory responsibilities.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and studies, as this information is not present in the provided text.
§ 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.