# K091912: B-Genin and R-Genin

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Jun 23, 2010 after 363 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
Longest line of descent: 1 generation back to K041168 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 1.
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004) Summary page 1.

## Most influential descendants
- K113791: B-Genin, R-Genin (2012), 0 descendants of its own

## Indications for use
B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Source page: https://510kreport.com/device/K091912
Methodology: https://510kreport.com/methodology