# K051188: Grafton DBM

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Jan 3, 2006 after 238 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 5 cite it directly.
0 of 8 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 its predicate without a number.
- (no number) human freeze dried bone, such as demineralized bone matrix: named in the summary without a submission number

## Most influential descendants
- K091729: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 2 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty (2014), 0 descendants of its own
- K100883: Carrigen (2010), 0 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
- 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

## Indications for use
GRAFTON® DBM 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®DBM 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® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is absorbed/remodeled and replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K051188
Methodology: https://510kreport.com/methodology