(47 days)
Pro Osteon 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Pro Osteon® 500R Resorbable Bone Graft Substitute is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes. Pro Osteon® 500R has a trabecular structure that resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster resorbing calcium carbonate, Calcium carbonate resorption will normally occur within six months or less. When Pro Osteon® 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon® 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.
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This document is a regulatory filing for a bone graft substitute, describing its indications for use, device description, contraindications, and regulatory clearance from the FDA. It does not involve AI or any performance metrics typically found in studies validating AI device performance.
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§ 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.