(28 days)
GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The granules or blocks may be pressed into the void or into the surgical site by hand. The GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.
GenerOs™ is a sterile osteoconductive bone void filler composed of ß-TCP. This synthetic bone graft comes in the shape of granules or blocks. GenerOs™ is supplied sterile for single patient use only. GenerOs™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.
This document pertains to a 510(k) premarket notification for a bone void filler and does not contain information about an AI/ML device or its acceptance criteria and study data. Therefore, I cannot provide the requested information.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.