# K030266: Cem-Ostetic Bone; Cemo-10G, Cemo-20G, Cemo-30G, Cemo-40G, Cemo-60G, CEM0-XXGC; Cemo-XYZ202005P, Cemo-XYZ20210P, Cemo-Xyz

- Pathway: 510(k) (Special)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Feb 20, 2003 after 24 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Cern-Osteticm is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-canceffous granules, blocks as well as injectable putty that are intended to be used to fill voids and gaps that are dot intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, peivis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and, pressed into the void by hand or inserted into a syringe and injected into the surgical sjte. Cem-OstetkTMprovides a void filler that can augment hardware to shpport bone fragments during the surgical procedure arid acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant i s radio-opaque. Cem-OstericTM is biocornpatible and resorbs in the body as bone ingrowth occurs.

Source page: https://510kreport.com/device/K030266
Methodology: https://510kreport.com/methodology