(124 days)
PRO-DENSE™ resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE™ is provided sterile for single use only.
For the PRO-DENSE™ Core Decompression Procedure Kit:
The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
For the Mixing and Delivery System:
The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.
PRODENSE is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRODENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.
The provided text describes a 510(k) premarket notification for a bone graft substitute, and therefore, does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered medical device.
The document discusses the PRODENSE™ Bone Graft Substitute and its intended use, technological characteristics, and substantial equivalence to predicate devices based on non-clinical evidence. It mentions dissolution, vicat set time, diametral tensile strength (DTS) testing, biocompatibility, and pyrogenicity testing to show the new mixing and delivery systems produce a graft that meets material specifications. However, this is not a clinical study proving device performance against acceptance criteria in the manner described by the request.
Therefore, I cannot provide the requested information from the given input.
§ 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.