(29 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 or 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, autograft, or synthetic bone graft material to an orthopedic surgical site.
PRO-DENSE Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.
The provided text is a 510(k) summary for the PRO-DENSE™ Bone Graft Substitute. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance and does not contain information regarding acceptance criteria, device performance, or a specific study designed to prove the device meets acceptance criteria.
The document details the device's indications for use, its components, and a comparison to a predicate device. It also lists non-clinical evaluations performed to support substantial equivalence, such as injection testing, biocompatibility assessment, and pyrogenicity testing. However, these are general assessments and not performance metrics against specific acceptance criteria for "device performance" in the context you've asked (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device).
Therefore, I cannot provide the requested information from the given text as it is not present in the document.
§ 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.