(144 days)
TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) 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.
TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.
TRIBONE 80™ is to be used in association with adequate post-operative immobilization.
TRIBONE 80™ is provided sterile for single patient use.
TRIBONE 80™ is a bone graft substitute. TRIBONE 80™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 20% Hydroxyapatite (HA) and 80% beta-Tricalcium Phosphate (ß-TCP). TRIBONE 80™ is available in granules, sticks and blocks. TRIBONE 80™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). TRIBONE 80™ can also be mixed with autograft. TRIBONE 80™ is provided sterile for single patient use.
This document is a 510(k) summary for TRIBONE 80™, a resorbable bone substitute. It details the device's identification, predicate devices, description, and intended use, as well as the substantial equivalence information. The document does not contain specific information regarding acceptance criteria, a study that proves the device meets those criteria, or details of algorithm performance (as it is a bone substitute, not an AI/software device).
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details like MRMC or standalone performance, as this type of information is not present in the provided text for a medical device that is a physical bone substitute.
§ 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.