# K140375: Mastergraft Putty, Mastergraft Strip

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 18, 2014 after 63 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- 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). 33 ancestors in all.
30 later devices descend from it; 17 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082166: Mastergraft Strip, Medtronic Sofamor Danek (2009) Summary page 1.
- K071813: Mastergraft Putty, Medtronic Sofamor Danek (2007) Summary page 1.

## Most influential descendants
- K181225: Altapore (2018), 6 descendants of its own
- K193075: Osteo3 ZP Putty (2020), 4 descendants of its own
- K192363: Altapore (2020), 4 descendants of its own
- K211201: MagnetOs Easypack Putty (2021), 3 descendants of its own
- K182074: Mineral Collagen Composite Bioactive Moldable (2019), 3 descendants of its own

## Indications for use
MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e.. the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water. and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis. ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Putty resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K140375
Methodology: https://510kreport.com/methodology