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The subject components. Osteonics® Spinal System Versatile Cross Connector, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Osteonics® Spinal System.

The uses for the legally marketed Osteonics® Spinal System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• . Vertebral fracture or dislocation
• . Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136 Titanium alloy (Ti-6AI-4V ELI). The Osteonics® Spinal System Versatile Cross Connector may be used in spinal applications where additional stability for the device construct is desired by the surgeon. The Osteonics Spinal System Versatile Cross Connector allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. The joining is intended to provide additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements.

The provided text is a 510(k) summary for the Osteonics® Spinal System Versatile Cross Connector. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document primarily states:

1. Acceptance Criteria (Implied): The mechanical and endurance properties of the subject components must be "within the range demonstrated by other existing spinal systems."
2. Study Type: "Fatigue and static testing" was performed.
3. Reported Device Performance: The testing "demonstrates the mechanical and endurance properties of the subject components are within the range demonstrated by other existing spinal systems."

Since this is a submission for substantial equivalence based

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