(76 days)
The Kaneda Anterior Spinal System is intended for use in:
- Idiopathic scoliosis.
- Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
- Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
- Neuromuscular scoliosis/kyphoscoliosis
- Spinal fractures (acute reduction or late deformity).
- Revision surgery.
- Tumor.
In addition, the Kaneda Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include: - Collapsing and unstable paralytic deformity.
- Progressively increasing scoliosis.
- Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- Inability to maintain sitting balance, necessitating the use of hands.
- Increasing pelvic obliguity coincident with back pain or loss of sitting balance.
The intended levels for treatment with the Kaneda Anterior Scoliosis System. are T4 to L4.
The Kaneda Anterior Scoliosis System is a construct that consists of two spinal staples, KASS blunt tip open and closed screws, standard Isola open and closed screws and 3/16 inch diameter Isola spinal rods.
KASS Spinal Staple:
The KASS spinal staple is made from ASTM F-138 implant grade stainless steel. The KASS spinal staple is available in a single or two-hole design.
The single hole KASS spinal staple is intended to be utilized in the thoracic spine, specifically when the anatomy of the spine restricts the use of a two-holed spinal staple. The single hole KASS spinal staple contains a centered single machined hole designed to accommodate a 6.25mm open or closed screw. The single hole KASS spinal staple is contoured in two planes. This design provides a more suitable fit when utilized in the thoracic spine. The single hole KASS spinal staple is available in one size.
The two-hole KASS spinal staple contains two machined holes placed diagonally across from one another. Both holes are designed to accommodate a 6.25mm open or closed screw. The two-hole KASS spinal staple is contoured in one plane which compliments the vertebral anatomy. The two-hole KASS spinal staple is etched with a ";" or "@" indicating the correct alignment of the spinal staples within a construct. In addition, a directional arrow (->) with the word "APEX" is etched on the twoholed KASS spinal staple. These etchings aid in the correct positioning of the two-hole spinal staple to ensure that the shortest spinal rod is posteriorly positioned in the construct. The two-hole KASS spinal staple is available in small, medium and large sizes.
Both the single and two-holed spinal staple are etched with an "A" for anterior placement and a "P" for posterior placement to the vertebral anatomy. All spinal staples are designed with four tetraspikes on the underneath side of the staple.
Spinal Screws:
The KASS and Isola standard screws are made from ASTM F-138 implant grade stainless steel. The KASS and Isola standard screws have a cancellous diameter of 6.25mm and connect to a 3/16 (4.75mm) diameter Isola spinal rod. The spinal screws are available in two designs. A standard Isola open and closed design and a KASS open and closed screw containing a blunt tip at the end of the cancellous portion of the screw. The KASS screw is intended for bi-cortical purchase of the vertebral body.
The closed KASS and standard Isola screws are designed to thread the spinal rod through the closed screw head. The open KASS and standard Isola screws are designed with a removable cap which allows the rod to be placed into the open screw head. The cap is re-applied to the head of the open screw capturing the spinal rod. Both the open and closed design KASS and standard Isola screws utilize a Isola set screw that tightens the spinal rod into the KASS screw.
The 6.25mm diameter KASS open and closed screws are available in twelve lengths which range from 25mm to 60mm in varying millimeter increments. The 6.25mm diameter standard Isola open and closed KASS screws are available in eleven lengths which range from 20mm to 70mm in 5 millimeter increments.
Spinal Rod:
The Isola spinal rod is made from ASTM F-138 implant grade stainless steel. The spinal rod is 3/16 inch (4.75mm) diameter and has a smooth surface. The spinal rod is cut to the required length needed for the KASS construct. The spinal rod is available in a 18 and 24mm length.
The provided text describes a medical device, the Kaneda Anterior Spinal System (KASS), and its regulatory clearance. However, it does not contain information about acceptance criteria, device performance from a clinical study, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical efficacy through detailed performance studies.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study that proves the device meets the criteria because the necessary information is not present in the provided text. The "Performance Data" section only lists "Non-Clinical: Mechanical characterization" and types of mechanical tests, not clinical performance metrics.
§ 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.