# K043048: Grafton Plus DBM Paste

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Nov 23, 2005 after 384 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: 15 (0 Class I)
- 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.
10 later devices descend from it; 1 cites it directly.
0 of 18 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, “AllomatrixPutty”.

## Most influential descendants
- K060794: Progenix DBM Putty and Paste (2006), 9 descendants of its own
- K072265: Progenix DMB Putty (2008), 4 descendants of its own
- K132868: Carricell (2015), 3 descendants of its own
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own

## Recalls of this device
- Aug 12, 2026 · Class II · Z-0137-2027: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. Whi
- Sep 26, 2023 · Class II · Z-0166-2024: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, b
- Feb 8, 2023 · Class II · Z-1329-2023: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
- Apr 20, 2012 · Class II · Z-0084-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0087-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0088-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0091-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0092-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0093-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0083-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0089-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0090-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0085-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0086-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co
- Apr 20, 2012 · Class II · Z-0094-2013: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become co

## Indications for use
Grafton Plus® DBM Paste is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) 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. Grafton Plus® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K043048
Methodology: https://510kreport.com/methodology