Manufactured using PEEK Optima LT1, the Stasys-C PEEK Cervical Standalone is a non-screw based, zero-profile, direct anterior standalone interbody system for the cervical spine. Designed to provide the greatest ease of use to the surgeon at every step of the procedure.
1. Non-screw-based fixation
2. Direct anterior approach allowing for a smaller, mid-line incision
3. Quick Turn Cam Lock—Locking feature that provides visual confirmation of engagement, but allows for anchor removal when desired
4. Quick, simple, non-impacting anchor insertion—does not need an awl or drill
5. Easily revised or removed—use of the removal instruments allows the locking mechanism to be bypassed so the anchors can be extracted. No drilling is required.
When used with integrated fixation as a standalone system:
The Stasys-C PEEK Cervical Standalone System is a standalone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Stasys-C PEEK Cervical Standalone System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without integrated fixation:
The Stasys-C PEEK Cervical Standalone System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2–T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
The Stasys-C PEEK Cervical Standalone System is offered in various device configurations based on surgical approach and patient anatomy. The Standalone Cervical Interbody is a machined PEEK interbody with two Anchor channels and a titanium alloy locking mechanism. The interbody is coupled with two (2) titanium alloy Anchors for integrated fixation.
The Stasys-C PEEK Cervical Standalone System may be implanted with or without Anchors. When used with the Anchors, it may be used as a standalone system and does not require supplemental fixation. However, the PEEK Standalone version may not provide adequate stability for all situations. Therefore, the Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior cervical screws) may be needed.
The Genesys Spine surgical instruments are designed to perform a specific function as referenced in the respective Genesys Spine surgical techniques. Such functions include but not limited to dissection, cutting, probing, clamping, gripping, handling, compressing, distracting, or inserting.
