# K043209: Viagraf DBM Paste

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Dec 5, 2005 after 381 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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: 3 generations back to K963562 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020078: Exactech Resorbable Bone Paste, Exactech, Inc. (2004) Summary page 1.
- K040755: Exactech Resorbable Room Temperature Bone Paste, Exactech, Inc. (2004) Summary page 1.
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004). Our reading of the summary gave K041186, FDA’s number for CADDY (Afikim Electric Vehicles). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Allomatrix Putty”.

## Indications for use
VIAGRAFO DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF 0 DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K043209
Methodology: https://510kreport.com/methodology