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510(k) Data Aggregation
(328 days)
The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems are temporary implants for use in orthopedic surgery. The systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
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Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
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Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:
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Spinal degenerative surgery, as an adjunct to spinal fusions.
The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.
The NILE Proximal Fixation Spinal System is a multiple component spinal fixation system intended for application to the thoracic, lumbar and sacral spine. The band is manufactured from polyethylene terephthalate (PET) and the connectors are made from titanium alloy in accordance with ASTM F136.
Function: The NILE Proximal Fixation Spinal System is designed to be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures.
The purpose of this submission is to add bands and connectors to the Nile system.
This document (K161332) is a 510(k) premarket notification for the NILE Proximal Fixation Spinal System. It asserts substantial equivalence to a predicate device, the K2M NILE Alternative Fixation Spinal System (K143350). The FDA has reviewed and determined the device is substantially equivalent for its stated indications for use.
Here's an analysis of the provided text to answer your questions regarding acceptance criteria and performance studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the NILE Proximal Fixation Spinal System in the traditional sense (e.g., minimum accuracy, sensitivity, or specificity values). Instead, the performance evaluation is based on a comparative study against predicate devices using recognized ASTM standards. The reported performance is a qualitative statement of equivalence or superiority.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance in static and dynamic compression | Performed equally to or better than predicate devices |
| Mechanical performance in static torsion | Performed equally to or better than predicate devices |
| Mechanical performance in static and dynamic tension | Performed equally to or better than predicate devices |
| Mechanical performance in axial slip | Performed equally to or better than predicate devices |
| Bacterial endotoxin limit |
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