Search Results

When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).

When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).

When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass.

Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).

The SCS Claris Spinal Screws Types V, G and E are available in outer (major) diameters ranging from 5.5 to 9.5mm in 1mm increments and cancellous lengths ranging from 25 to 55mm in 5mm increments.

The provided 510(k) summary (K011807) describes the SCS Claris Spinal Screws Types V, G, and E. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, the summary focuses on establishing substantial equivalence to a previously cleared device (SCS Claris Spinal Screws Types V, L, and R). Substantial equivalence is determined based on:

• Equivalence in indications/intended use: The new screws are intended for the same clinical applications.
• Manufacturing methods: The production processes are similar.
• Interconnection (attachment) mechanism: How the screws integrate with other spinal instrumentation is consistent.
• Basic design: The fundamental structural characteristics are alike.
• Materials: The materials used (stainless steel and titanium alloy) are the same as the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions 2-9, as those pertain to a performance study that is not detailed in this 510(k) summary. The FDA's letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the devices are substantially equivalent (for the indications for uses stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the approval is based on equivalence to a predicate device, not on a new performance study demonstrating specific acceptance criteria.

Ask a specific question about this device