Search Results

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for anterolateral screw/staple fixation of the T6-L5 spine, is intended for the following indications:

• a) Degenerative disc disease (ddd) this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• b) Spondylolisthesis
• c) Trauma (i.e., fracture or dislocation)
• d) Spinal stenosis;
• e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• f) Tumor
• g) Pseudarthrosis
• h) Previous failed fusion.

The Blackstone™ Spinal Fixation System Staple & Washer (System Modification) are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components. These devices are an adjunct to the Spinal Fixation System, which allows a surgeon to build a spinal implant construct. The system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The devices added to the current Spinal Fixation System are listed below with a brief description.

Staple:
The Staple is available in one diameter and three thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Staple has a conical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components. Furthermore, the device has three prongs with a trocar tip which fix's the device to a vertebral body.

Washer:
The Washer is available in one diameter and three thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Washer has a conical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components.

I am sorry, but the provided text describes a 510(k) summary for a medical device (Blackstone™ Spinal Fixation System Staple & Washer) and does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The document is primarily focused on describing the device, its intended use, and establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the criteria.

Ask a specific question about this device