(55 days)
The Trifore™ Cervical Plating System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Trifore™ Cervical Plating System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Trifore™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Trifore™ Cervical Plating System implant components are made from titanium alloy such as described by ASTM F136.
The provided text describes a medical device, the Trifore™ Cervical Plating System, and its substantial equivalence to predicate devices, but it does not contain the information requested in points 1 through 9 regarding acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) premarket notification for a spinal fixation device, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The "performance data" section only mentions mechanical testing to ASTM F1717-14 standards, which are general engineering standards for spinal implant constructs, not specific clinical or diagnostic performance criteria.
Therefore, I cannot extract the requested information from the provided text.
The information I can confirm from the text is:
- Device Name: Trifore™ Cervical Plating System
- Regulatory Class: Class II (Product Code: KWO, although later listed as KWQ in the 510(k) summary)
- Indications for Use: Anterior cervical fixation (C2-T1) for degenerative disc disease (DDD), spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.
- Materials: Titanium alloy such as described by ASTM F136.
- Predicate Devices: Transom™ Cervical Plating System (K142060), Tempus™ Cervical Plating System (K120515, K131374), CSLP System (K030866).
- Performance Data Type: Non-clinical mechanical testing (Static axial compression bending, Static torsion, Dynamic axial compression bending fatigue per ASTM F1717-14).
- Conclusion: The device is substantially equivalent to predicate devices based on overall technology characteristics and mechanical performance data.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.