# K140374: Mastergraft Putty

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 10, 2014 after 116 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: 8 generations back to K960978 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081784: Mastergraft Putty, Medtronic Sofamor Danek (2008) Summary page 1.

## 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/K140374
Methodology: https://510kreport.com/methodology