(325 days)
ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS® is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ORTHOSS® Resorbable Bone Void Filler is intended to be used in the spine only for posterolateral fusion.
ORTHOSS® is a natural non-antigenic, porous bone mineral. It is produced by removal of all organic components from bovine bone. Due to its natural structure, it is physically and chemically comparable to the mineralized matrix of human bone.
This document, a 510(k) summary for ORTHOSS® Resorbable Bone Void Filler, does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It states that:
- The only change from the previously cleared ORTHOSS® product (K01-4289) is the source of the bovine bone, which has shifted from the U.S. to Australia.
- Australia is considered a low-risk country for BSE, and this change in source is deemed not to negatively impact the safety of the product.
Therefore, I cannot provide the requested information. The 510(k) process for this specific device relied on demonstrating that the new version is substantially equivalent to a previously approved device, rather than presenting new performance data against acceptance criteria.
§ 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.