# K023703: BI-Ostetic

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Jan 30, 2003 after 87 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K050789: Formagraft Collagen Bone Graft Matrix (2005), 11 descendants of its own
- K091031: Pioneer Surgical Nanoss BVF-E (2009), 7 descendants of its own
- K110561: Fortross Bone Void Filler (2011), 4 descendants of its own
- K141600: Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit (2014), 3 descendants of its own
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own

## Indications for use
Bi-OsteticTM is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The Bi-OsteticTM granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-OsteticTM is biocompatible and resorbs in the body as bone ingrowth occurs.

Source page: https://510kreport.com/device/K023703
Methodology: https://510kreport.com/methodology