# K023553: Mastergraft Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Apr 22, 2003 after 181 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: 2 generations back to K990131 (1999). 3 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 43 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). Our reading of the summary gave K020956, FDA’s number for Vivosonic Dianostic Ultrasound Imaging Coupling Media (Microtek Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MasterGraft Resorbable Ceramic”.
- K012506: Mastergraft Resorbable Ceramic Granules, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- 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

## Indications for use
MasterGraftTMMatrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraftTM Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraftTM Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K023553
Methodology: https://510kreport.com/methodology