(31 days)
Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
The provided document K051123, a 510(k) Pre-Market Notification for the Callos™ Bone Void Filler, does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, this submission is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not significantly affect the safety or effectiveness of the device. In this instance, the modification is described as a "modification in materials" for the Callos Bone Void Filler, which was previously cleared under K030554.
The submission states: "This Special 510(k) proposes a modification in materials for Callos, which was previously cleared under K030554 on May 20, 2003. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Callos remain the same as in the predicate cleared 510(k)s. ... The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of Callos."
Therefore, this specific document does not report on a study with acceptance criteria and device performance metrics because it relies on the previous clearance (K030554) for establishing substantial equivalence. The focus of this submission is on demonstrating that the change in material does not alter the fundamental safety and effectiveness profile already established for the predicate device.
To answer your request, one would need to refer to the original 510(k) submission (K030554) for Callos Bone Void Filler, as that is where clinical performance data and acceptance criteria would likely be presented, if required for that initial clearance. This current document (K051123) is an approval for a material modification, not an initial market clearance that would typically include such a study.
§ 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.