# K042707: Grafton Plus DBM Paste

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Nov 30, 2005 after 426 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K852682 (1985). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960267: TBM Sponge, Biocoll Laboratories, Inc. (1996) Summary page 1.
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 1.
- K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3, Bioform, Inc. (2003) Summary page 1.
- K031073: Perioglas Plus - Settable Bone Graft Substitute, Novabone Products, LLC (2003) Summary page 1.
- (no number) Human freeze dried bone, such as demineralized bone matrix: named in the summary without a submission number

## 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
- 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 to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodeled and replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K042707
Methodology: https://510kreport.com/methodology