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The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of rods, pedicle screws, connectors and fasteners. Rods are available in either straight, or pre-contoured (curved) or revision forms in a variety of lengths. Pedicle screws are available in modular and non-modular polyaxial, and non-modular uniplanar designs having double lead standard or cortical/cancellous thread forms in a variety of diameter-length combinations. Connectors include offset, various wedding band options and transverse rod-to-rod. Set screws are used to fasten the components. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants may be sold sterile or nonsterile.

This document is a 510(k) Premarket Notification for a medical device called the "INERTIA® CONNEXX™ Modular Pedicle Screw System." It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

Based on the provided text, the device in question is a pedicle screw system for spinal immobilization and stabilization, not an AI/software-driven diagnostic tool. Therefore, the information typically requested in questions 1-9 (related to acceptance criteria for AI algorithms, sample sizes for training/test sets, expert adjudication, MRMC studies, etc.) is not applicable to this type of device submission.

The "Performance Data" section explicitly states:

• "Mechanical testing of worst case INERTIA® CONNEXX™ constructs included dynamic compression bending according to ASTM F1717."
• "The results demonstrate that INERTIA® CONNEXX™ Modular Pedicle Screw System performance is substantially equivalent to the predicate."

This indicates that the acceptance criteria and proof of performance are based on mechanical testing of the physical device to ensure it meets established ASTM standards and is comparable to previously cleared devices, rather than on the performance of a diagnostic algorithm or human-AI interaction.

Therefore, I cannot provide answers to questions 1-9 regarding acceptance criteria and study details for an AI-driven device, as this document describes a physical spinal implant.

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