(92 days)
The CD HORIZON® Spinal System with or without SEXTENT® instrumentation 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; pseudarthritis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications.
With the exception of degenerative disc disease, the CD HORIZON LEGACY 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients.
The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device intended for use 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 (as previously defined); spondylolisthesis, trauma; and/or tumor.
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 case. 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 Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic 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 add modified screws and lateral connectors to the CD HORIZON® Spinal System.
The provided text is a 510(k) summary for the CD HORIZON® Spinal System. This type of submission is for medical devices seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Instead, the document focuses on:
- Product Description: Details of the components and function of the CD HORIZON® Spinal System.
- Intended Use/Indications: Specifies the medical conditions for which the device is intended.
- Substantial Equivalence: States that documentation (including a Risk Analysis) was provided to demonstrate substantial equivalence of the new components (modified screws and lateral connectors) to previously cleared CD HORIZON® Spinal System components (K042025 and K020709). The labeling is also stated to be identical to a previously cleared system (K060203).
The FDA's letter (pages 2-3) confirms the "substantial equivalence determination" based on the marketing of legally marketed predicate devices, not on a new study showing performance against acceptance criteria.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.