(96 days)
The Resorbable Mesh Pouch, once filled with autograft, is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use in the posterolateral spine and pelvis as a bone void filler and bone graft extender. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Ultimately, the Resorbable Mesh Pouch will be resorbed.
The Resorbable Mesh Pouch is comprised of an empty bioresorbable poly(lactic-co-glycolic) acid (PLGA) pouch (open at one end and sealed at the other) and disposable polypropylene accessories. Utilizing the provided accessories, the Resorbable Mesh Pouch is to be filled with autograft by the clinician at the time of the procedure. Once filled, the Resorbable Mesh Pouch is to be closed using 2-0 Vicry1® sutures available to the clinician in the Operating Room (not provided with the finished device). The filled, closed device is intended to be implanted into the posterolateral spine and pelvis.
The Resorbable Mesh Pouch is provided in individually sterile packaged units. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-6.
This document is a 510(k) summary for the Resorbable Mesh Pouch (Ballast® MT, OsteoBallast® MT) and does not describe acceptance criteria or a study proving that a device meets those criteria. The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance 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.