Search Results

Biofill is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Biofill is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Biofill should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Biofill is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Biofill Bone Void Filler is a tricalcium phosphate bone void filler.

It is supplied in the form of parallelevined granules measuring 1mm-4mm on each side. It is marketed in quantities of Scc, 10cc and 15cc dosages.

The Biofill structure is made up of intercomected macroporcs occupying 60-80% of the granule. Pore size is 200-700um with an average of 400μm. Microporosity is also present with pore size

The provided text describes a 510(k) premarket notification for a medical device called "Biofill Bone Void Filler." This submission focuses on establishing substantial equivalence to existing predicate devices based on material, indications, and use, rather than presenting a study with specific acceptance criteria and performance data for a new AI/software-based device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in the provided document.

The document mainly includes:

• Device Description: Biofill Bone Void Filler is a tricalcium phosphate bone void filler, supplied as parallelepiped granules with specific dimensions and porosity.
• Intended Use/Indications for Use: Detailed description of its purpose as a bone void filler for non-stability intrinsic voids/gaps in surgically created or traumatic osseous defects, to be replaced by bone during healing.
• Equivalent Device: Biofill is deemed equivalent to BIOSORB (K021963) and Vitoss™ Scaffold (K994337) in material, indications, and use.
• Nonclinical Tests: It complies with ASTM F1088-87, "Standard specification for beta tricalcium phosphate for surgical implantation."
• Regulatory Information: 510(k) number (K040454), regulation number (21 CFR 888.3045), regulation name (Resorbable calcium salt bone void filler), regulatory class (II), and product code (MOV).

This is a traditional medical device submission for a physical implant, not a software as a medical device (SaMD) or AI-powered solution. Therefore, the structure of the requested information (which is typical for AI/software evaluations) does not apply to this context.

Ask a specific question about this device