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The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degencrative 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) svondylolisthesis. (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) turnor resection, and/or (8) failed previous fusion.

ORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment intended to spinous process for the purpose of achieving supplemental fusion in the following conditions: ive disc disease - defined as back pain of discogenic origin with degeneration of the disc degenara by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or confir n); and/or tumor. disloc

HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle tation system of the non-cervical posterior spine in skeletally mature patients, are for one or more of the following: (1) degenerative spondylolisthesis with objective indicat of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) evider i spinal amor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having sever spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw system in skeletally mature patients, the CI) HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degencrative (1) degencrative (1) 1 spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORLZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual casc. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danck spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSI.INK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medironic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to include additional CD HORIZON® SEXTANT instruments, CD HORIZON® fixed angled screws and modified rods to the CD HORIZON® Spinal System.

This document is a 510(k) premarket notification for the CD HORIZON® Spinal System from September 2005. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, the prompt's request for detailed information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert qualifications, and ground truth establishment is not directly applicable to this type of regulatory submission. The document explicitly states:

• "Documentation, including a risk analysis, was provided which demonstrated the subject instruments to be substantially equivalent to predicate CD HORIZON® SEXTANT instruments previously cleared in K051674 (07/21/05) and K043343 (SE 12/28/04) and to implants cleared in the CD HORIZON® Spinal System cleared in K042790 (11/4/04) and K050809 (SE 06/14/05)."

This means the "study" for this submission is a comparison to predicate devices to establish substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness profiles, rather than a clinical trial or performance study against predefined numerical acceptance criteria.

Based on the provided text, none of the requested information regarding acceptance criteria and a study proving device performance can be extracted as it relates to this 510(k) submission. The document is a regulatory communication for substantial equivalence, not a scientific study report.

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