(75 days)
HEALOS® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may he surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.
HEALOS Fx Injectable Bone Graft Replacement is a mineralized collagen matrix processed into lyophilized fibrous material for surgical implantation. The principal components of the HEALOS Fx Injectable Bone Graft Replacement are Type I bovine collagen and hydroxyapatite. HEALOS Fx is approximately 20-30% mineral by weight.
The HEALOS Fx Graft Mixing and Delivery System is designed to facilitate the mixing of autogenous bone marrow aspirate with the HEALOS Fx material and to deliver this bone graft mixture into the surgical site. Included in the kit are two chambers: a mixing chamber and a delivery chamber.
The provided text is related to a 510(k) premarket notification for a medical device called HEALOS® Fx Injectable Bone Graft Replacement and its associated Mixing and Delivery System. This document is a regulatory submission to the FDA, primarily focusing on establishing substantial equivalence to predicate devices for market clearance.
As such, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.
The "Performance Data" section explicitly states: "No performance standards have been established for this type of device." This indicates that the regulatory pathway for this device did not require a study with quantitative performance metrics against pre-defined acceptance criteria for the purpose of this 510(k) submission. Instead, the focus is on a comparison to existing legally marketed devices.
Therefore, I cannot provide the requested information from this 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.