(30 days)
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe 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 screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:
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- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
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- Idiopathic scoliosis.
- Kyphotic deformities of the spine. 3.
- Paralytic scoliosis and/or pelvic obliquity.
- Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity. 6.
- Vertebral fracture or dislocation. 7.
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- Tumors.
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- Spondylolisthesis.
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- Stenosis.
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- Pseudarthrosis.
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- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Adjustable Length Rod is intended for in situ adjustment of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
The Synergy™ Spinal System components are grouped as follows:
Posterior Application:
- Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with 1. Variable Locking Seats and Iliac Screws with Hex Nuts and Set Screws. Caution: Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
- Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws. 2.
- Adjustable and Fixed Transverse Connectors with Set Screws. 3.
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- Closed and Axial Rod Connectors with Set Screws.
- Lateral Connectors with Set Screws. 5.
- Rods and Adjustable Length Rods and Set Screws. 6.
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- Instruments.
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- Sterilizer case(s).
Anterior Application:
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- Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
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- Vertebral Washers.
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- Fixed Transverse Connectors with Set Screws.
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- Rods.
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- Instruments.
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- Sterilizer case(s).
NOTE: While the Variable Locking Screws and some fasteners (nuts and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters.
NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.
The provided text is a 510(k) summary for a medical device (Spinal Intervertebral Body Fixation Orthosis - Synergy™ Spinal System) and details its indications for use and comparisons to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested table and study details. This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than presenting performance data from a clinical or technical study against specific acceptance criteria.
The key phrase that indicates the nature of this submission is:
"Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Synergy Spinal System is considered substantially equivalent to the legally marketed predicate device."
This means the device's approval is based on its similarity to an already approved device, rather than new, independent performance testing against defined 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.