# K081784: Mastergraft Putty

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Sep 17, 2008 after 85 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960978 (1996). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071813: Mastergraft Putty, Medtronic Sofamor Danek (2007) Summary page 2.
- K010701: Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 2.
- K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3, Bioform, Inc. (2003) Summary page 2.
- K062834: Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050, Genoss Co., Ltd. (2007) Summary page 2.
- K051885: MBCP, Biomatlante (2005)

## Most influential descendants
- K140374: Mastergraft Putty (2014), 0 descendants of its own

## Indications for use
MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include: Filling of periodontal defects Filling of dental extraction sockets Filling of cystic defects Sinus lifts Alveolar ridge augmentation Oral/maxillofacial augmentation or reconstruction. MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Source page: https://510kreport.com/device/K081784
Methodology: https://510kreport.com/methodology