AIS-C Standalone System
The AIS-C® Standalone System is a zero-profile, direct-anterior, standalone interbody system for the cervical spine. It was designed to provide the greatest ease of use to the surgeon at every step of the procedure.
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1. Non-screw-based fixation
2. Direct anterior approach allowing for a smaller, mid-line incision
3. Zero-step locking mechanism – Contains a 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
About the AIS-C Standalone System
- The interbodies are offered in small (14mm width x 12mm length) and large (17mm width x 14mm length) footprints.
- Interbody heights range from 5mm to 12mm. Please reference the surgical technique for recommend pairing of anchors to interbodies.
- Genesys Spine does not recommend any protrusion length less than 5mm or more than 8mm.
Indications for Use:
The Genesys Spine 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 Genesys Spine Cervical Standalone System is to be used with autogenous bone graft and implanted via an anterior approach.
Description and Intended Use:
The Genesys Spine AIS-C Cervical Standalone System will be offered in various device configurations based on surgical approach and patient anatomy. The Genesys Spine AIS-C Cervical Standalone System includes an interbody, containing a titanium alloy locking mechanism, that is implanted with two (2) titanium alloy bone anchors. The interbody is offered in either PEEK or in titanium alloy.
The integrated fixation anchors may not provide adequate stability for all situations. 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 are not limited to dissection, cutting, probing, clamping, gripping, handling, compressing, distracting, or inserting.
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AIS-C Standalone System
