# K082917: Mastergraft Resorbable Ceramic Granules

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Jan 9, 2009 after 101 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: 5 generations back to K990131 (1999). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020986: Mastergraft Resorbable Ceramic, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K051885: MBCP, Biomatlante (2005) Summary page 1.

## Most influential descendants
- K100986: Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation (2010), 0 descendants of its own
- K093871: Periophil B-TCP (2010), 0 descendants of its own
- K092087: Medtronic Dental TCP (2009), 0 descendants of its own

## Indications for use
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules 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 specific to MASTERGRAFT® Granules include: • Filling of dental extraction sockets • Filling of cystic defects • Oral/maxillofacial augmentation or reconstruction. Procedures specific to MASTERGRAFT® Mini Granules include: • Filling of periodontal defects • Sinus lifts • Alveolar ridge augmentation • Filling of dental extraction sockets • Filling of cystic defects • Oral/maxillofacial augmentation or reconstruction. MASTERGRAFT® Resorbable Ceramic Granules 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/K082917
Methodology: https://510kreport.com/methodology