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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scollosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: degenerative disc disease (DDD) (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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System.is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to incorporate additional screws and rods into the system.

The provided text is a 510(k) summary for the K2M Range Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study where a device's performance is measured against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document.

The document states:

• Acceptance Criteria/Reported Device Performance: Not explicitly defined or reported in terms of specific performance metrics. The claim is based on substantial equivalence to predicate devices.
• Study Proving Acceptance Criteria: The study proving substantial equivalence is an "Engineering rationales were used to compare the modified implants to predicate devices that were previously tested in static compression, static torsion and dynamic compression in accordance with ASTM F 1717." This is a mechanical engineering comparison, not a clinical study involving human or animal data.
• Sample Size for Test Set and Data Provenance: Not applicable as it's an engineering comparison to predicate devices, not a test set for an algorithm or a clinical trial.
• Number of Experts and Qualifications: Not applicable as no ground truth was established by experts for a test set.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No MRMC study was performed or mentioned.
• Standalone Performance Study: No standalone clinical performance study was done; the evaluation relied on substantial equivalence through engineering rationales.
• Type of Ground Truth Used: The ground truth used is the ASTM F 1717 standard for mechanical testing, which served as the benchmark for comparing the modified implants to the predicate devices.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on engineering comparisons and previous testing of predicate devices against established ASTM standards, rather than presenting a performance study against novel acceptance criteria with clinical data.

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