# K050666: Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-Xyz Series, GO-DZ Series

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Apr 11, 2005 after 28 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 K994337 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023703: BI-Ostetic, Berkeley Advanced Biomaterials, Inc. (2003) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.

## Indications for use
GenerOsTM 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 GenerOsTM 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. GenerOsTM is biocompatible and resorbs in the body as bone ingrowth occurs.

Source page: https://510kreport.com/device/K050666
Methodology: https://510kreport.com/methodology