(17 days)
The BASIS™ anterior cervical plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
The BASIS™ anterior Thoracic and Lumbar plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
When used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS™ components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
The BASIS™ Spinal System components included in this submission consist of screws, bolts, nuts and plates as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The BASIS™ Spinal System implant components are made from titanium alloy.
The provided document is a 510(k) premarket notification for the BASISTM Spinal System. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving device performance through a standalone study with specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:
- No acceptance criteria or reported device performance are presented. The document focuses on regulatory approval based on equivalence.
- No sample size for a test set or data provenance is mentioned.
- No information on experts or ground truth establishment is provided for a performance study.
- No adjudication method is described.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is discussed.
- No standalone (algorithm only) performance study is mentioned.
- No type of ground truth used for a performance study is specified.
- No sample size for a training set or how ground truth was established for it is provided.
The document indicates that the BASISTM Spinal System was determined to be "substantially equivalent" to several predicate devices, including:
- SYNTHES® Cervical Vertebrae Plates (K792352)
- SYNTHES® Spinal Implant System (K802462)
- ORION® Anterior Cervical Plate System (K973854)
- ZPLATE-ATL™ Anterior Fixation System and ZPLATE-ATL™ Anterior Fixation System ZPLATE-II (K922543 and K990603)
- VANTAGE™ Anterior Fixation System Plate (K023797)
The indications for use for the BASISTM Spinal System are the same as those for the predicate devices, covering various spinal conditions such as spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, and failed previous fusion.
§ 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.