# K082166: Mastergraft Strip

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Jun 2, 2009 after 306 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: 7 generations back to K960978 (1996). 32 ancestors in all.
38 later devices descend from it; 7 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023553: Mastergraft Matrix, Medtronic Sofamor Danek, Inc. (2003) Summary page 2.
- K071813: Mastergraft Putty, Medtronic Sofamor Danek (2007) Summary page 2.
- K052812: Ossimend (TM) Bone Graft Material, Collagen Matrix, Inc. (2006) Summary page 2.
- K000122: Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box), Neucoll, Inc. (2001) Summary page 2.
- K063124: Integra Mozaik Bone Regeneration Matrix - Strips, Integra Lifesciences Corp. (2007) Summary page 2.

## Most influential descendants
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K082166
Methodology: https://510kreport.com/methodology