Device Information

The Rebuilder Nerve Guidance Conduit is made of bioresorbable poly(lactide-co-caprolactone), a permeable material designed to protect and support peripheral nerve regeneration. It is available in various sizes, with inner diameters ranging from 1.5 mm to 10 mm, and is provided sterile for single use only. The device is packaged in a double-peel package to ensure sterility and protection until use.

Indications

Rebuilder Nerve Guidance Conduit is indicated for reconstructing a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete nerve division.

Intended Use

The device is intended for surgeons to use in reconstructing peripheral nerve injuries where a gap of up to 20 mm exists due to complete nerve division. It provides a protective environment and guides axonal growth across the gap to promote nerve repair.

Availability

The device is available by prescription only.

Study Results

Non-clinical tests on mechanical strength and biocompatibility demonstrated that the Rebuilder Nerve Guidance Conduit is safe and effective for its intended use. Animal testing using a rat sciatic nerve model showed the device promotes nerve repair and functional recovery.

Regulatory Information

• Regulation Number: 21 CFR 882.5275
• Regulatory Class: Class II
• Product Code: JXI
• 510(k) Number: K230794

The device is subject to Quality System (QS) regulations under 21 CFR Part 820, and manufacturers must comply with additional requirements related to registration, labeling, and adverse event reporting.

Manufacturer Information

• Manufacturer Name: CelestRay Biotech Company, LLC
• Address: P.O. Box 341754, Bethesda, MD 20827-1754
• Contact: Shanshan Xu, CTO and Partner

Predicate Device Information

• Predicate Device Name: Neurolac Nerve Guide ( K112267, K050573)
• Reference Device: Neurogen Nerve Guide (K011168)
• Is the Predicate Device an Earlier Version?: No
• Differences: The Rebuilder Nerve Guidance Conduit differs from the Neurolac Nerve Guide primarily in its material composition, which uses poly(lactide-co-caprolactone) instead of poly(lactic-co-glycolic acid). The Rebuilder offers similar mechanical strength and resorbability while promoting axonal growth across nerve gaps in vivo animal testing using a rat nerve sciatic nerve transection model.

Implications

The device provides an option for peripheral nerve repair. It reduces the need for autografts to help restore nerve function after injury.

References

1. Rebuilder Nerve Guidance Conduit. 510(k) Number K230794. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K230794
2. https://fischellinstitute.umd.edu/news/story/celestray-secures-fda-clearance-for-implantable-medical-device-with-help-from-fischell-institute