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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bory fusion and aid in the repart of bone fractures. The include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction surgery, incorporated into construction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The CD Horizon™ Spinal System with or without Sextant™ intended for posterior, non-cervical fixation as an adjunct o fusion for the following indications: degenerative disc disease (DDD - defined as back pain with degeneration of the disc confirmed by history and radios). spondylolisthesis, trauma (i.e. fracture or dislocation), soinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis). tumor, pseudarthrosis, and or failed previous fusion. Except for hooks, when used as an anterclateral the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, the CD Horizon™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted below.

When used for posterior non-cervical pediation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to freat progressive spinal deformities (i.e. scolosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the CD Horizon™ Spinal System is intended to tred pediativ patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and or failed previous fision. These cevices are to be allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the ing supplemental fixation in the following conditions: DDD (as reviously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert indications of use . Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

The purpose of this submission is to expand use of the previously cleared LigaPASS® Spinal System with the previously cleared CD Horizon™ 5.5/6.0 Spinal System rods.

LigaPASS® Spinal System: The LigaPASS® MEDICREA® INTERNATIONAL S.A. spinal system is composed of four components: a connector, two set screws and a band. The LigaPASS® system is designed to stabilize a vertebra in the same manner as a hook around the vertebra during development of solid bony fusion. The LigaPASS® system must be implanted via a posterior approach to complete a thoraco-lumbar fixation system as the PASS LP® MEDICREA® INTERNATIONAL S.A. spinal system. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136, with the exception of the band which is manufactured in polyethylene terephtalate (PET) and titanium T40 conforming to ISO 5832-2 specifications and ASTM F67.

CD Horizon™ Spinal System: The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a 510(k) premarket notification clearance letter from the FDA for a spinal system, discussing its substantial equivalence to predicate devices and detailing its indications for use, product description, and a general statement about performance testing. It mentions mechanical testing in accordance with ASTM 1798 but does not provide specific acceptance criteria or study results.

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