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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The purpose of this 510(k) submission is to add an adjustable-length spinous process fusion plate to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F136 and ASTM F1537, Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

This 510(k) summary describes a spinal fixation system, which is a physical device rather than a software or AI-driven medical device. Therefore, many of the requested categories related to acceptance criteria, ground truth, expert review, and comparison to AI performance are not applicable.

Here's a breakdown of the available information based on your request, highlighting where the information is not relevant for a physical medical device:

Acceptance Criteria and Device Performance for Lanx Spinal Fixation System (K121316)

The submission focuses on demonstrating the substantial equivalence of new components (an adjustable-length spinous process fusion plate) to a previously cleared system and predicate devices. The "acceptance criteria" are primarily related to mechanical performance standards.

Information Not Applicable to this Device (Physical Spinal Fixation System):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a physical implant. The "test set" here refers to the physical samples of the device components.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is established by engineering standards and measurements, not expert clinical interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/software device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective performance standards outlined in the ASTM standards (e.g., specific force, displacement, or fatigue cycles).
7. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical testing of a physical medical device.
8. How the ground truth for the training set was established: Not applicable.

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