# K051195: Grafton DBM

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Dec 16, 2005 after 220 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: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
140 later devices descend from it; 11 cite it directly.
0 of 141 devices 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.

## Most influential descendants
- K060728: Novabone Putty - Bioactive Synthetic Graft (2006), 120 descendants of its own
- K080009: Novabone Putty- Bioactive Synthetic Graft (2008), 71 descendants of its own
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft (2008), 59 descendants of its own
- K072184: Vitoss Bioactive Foam Bone Graft Substitute (2007), 51 descendants of its own
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute (2008), 50 descendants of its own

## Recalls of this device
- Aug 12, 2026 · Class II · Z-0138-2027: 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-0161-2024: 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
- Sep 26, 2023 · Class II · Z-0163-2024: 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
- Sep 26, 2023 · Class II · Z-0164-2024: 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
- Sep 26, 2023 · Class II · Z-0165-2024: 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
- 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
- Sep 26, 2023 · Class II · Z-0167-2024: 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
- Sep 26, 2023 · Class II · Z-0162-2024: 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-1324-2023: 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.
- Feb 8, 2023 · Class II · Z-1325-2023: 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.
- Feb 8, 2023 · Class II · Z-1327-2023: 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.
- Feb 8, 2023 · Class II · Z-1333-2023: 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.
- Feb 8, 2023 · Class II · Z-1326-2023: 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.
- Feb 8, 2023 · Class II · Z-1328-2023: 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.
- Feb 8, 2023 · Class II · Z-1323-2023: 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.
- Jan 6, 2014 · Class II · Z-0977-2014: Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
- 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
- Aug 8, 2011 · Not classified · Z-0416-2012: Aseptic conditions during the production of these products may have been compromised.
- Aug 8, 2011 · Not classified · Z-0415-2012: Aseptic conditions during the production of these products may have been compromised.

## Indications for use
GRAFTON® DBM 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® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K051195
Methodology: https://510kreport.com/methodology