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The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN™ interbody device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The accompanying cover plate is designed to resist screw backout and must be used when screws are implanted. The implant is lens-shaped with three holes for placement of titanium screws. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.

The SOVEREIGNTM Spinal System interbody device is manufactured from PEEK Optima (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy:

This document is a 510(k) premarket notification for the SOVEREIGN™ Spinal System. It asserts substantial equivalence to a previously cleared device (INTREPID™ Spinal System) and does not contain detailed acceptance criteria and performance study results as would be found in a clinical trial report.

Therefore, the requested information cannot be fully extracted or inferred from the provided text. Specifically, clinical study data, acceptance criteria tables, sample sizes for test and training sets, details on expert panels, adjudication methods, or MRMC study results are not present in this document.

The document focuses on:

• Device Description: The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation, made from PEEK Optima with tantalum markers.
• Indications for Use: For degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with autogenous bone graft, in skeletally mature patients who have had six months of non-operative treatment. Can be used stand-alone with three screws and a cover plate, or with supplemental fixation if fewer or no screws are used.
• Substantial Equivalence: The primary basis for clearance is substantial equivalence to the INTREPID™ Spinal System (K080083). Minor changes to labeling (indications, device description, contraindications).
• Regulatory Classification: Class II, regulated under 21 CFR 888.3080 (Intervertebral body fusion device).

No information regarding acceptance criteria or a specific study demonstrating performance against such criteria (as you would expect for a new, significant technological device) is provided in this 510(k) summary. This type of premarket notification for devices like the SOVEREIGN™ Spinal System often relies on demonstrating mechanical equivalence and biocompatibility, and substantial equivalence to a predicate device, rather than new clinical efficacy studies with predefined acceptance criteria.

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