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The VERSALOK Low Back Fixation System is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature.

1. A construct with screws attached to the pedicles of the lumbar and sacral spine (1,3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (grade 3 or 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warning below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
2. When not used as a pedicle screw fixation system, various combinations of the VERSALOK components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
   a) Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
   b) Degenerative disk diseases of the spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
   c) Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
   Progressive, despite other forms of treatment,
   Detrimental to cardiopulmonary function,
   Interfering with spinal mechanics or causing severe back pain, or
   Cosmetically unacceptable, progressive, and painful.
   For the above indications, use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
3. The VERSALOK Low Back Fixation System is also a pedicle screw system 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The VERSALOK is a posterior spinal fixation system consisting of various types and sizes of implantable components (screws, rods, couplers, etc.) that are assembled to create a spinal construct. It features a low profile as well as a top loading design. The VERSALOK is offered for sale both in stainless steel and titanium.

The VERSALOK Low Back Fixation System underwent mechanical testing to demonstrate its performance characteristics.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the sample size used for the mechanical testing. The data provenance is not specified beyond indicating it was performed by Osteotech, Inc.

3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable as the study involved mechanical testing of a physical device, not an expert-driven assessment.

4. Adjudication Method for Test Set:
Not applicable for mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted as this is a mechanical device, not typically requiring such a study.

6. Standalone Performance (Algorithm Only):
Not applicable, as this is a physical medical device and not an AI algorithm.

7. Type of Ground Truth Used:
The ground truth was established through mechanical testing of the VERSALOK constructs against established ASTM standards and in comparison to predicate devices.

8. Sample Size for Training Set:
Not applicable, as the document refers to post-market mechanical testing for device performance comparison, not a training set for an algorithm.

9. How Ground Truth for Training Set Was Established:
Not applicable.

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