510(k) · Cleared

Cleared

Mastergraft Resorbable Ceramic Granules

K012506510(k) TraditionalCleared Mar 7, 2002213-day reviewClass II21 CFR 888.3045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Sofamor Danek USA, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Mar 7, 2002 after a 213-day review. The FDA summary names no predicate by number. 61 later devices descend from it.

Decided: Mar 7, 2002
Review: 213 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 0

61 later devices descend from it, 4 citing it directly.

This deviceK012506 Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek USA, Inc. · 2002
Descendant · cites it directly · 59 of its ownK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
Descendant · cites it directly · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
Descendant · cites it directly · 39 of its ownK023553 Mastergraft MatrixMedtronic Sofamor Danek, Inc. · 2003
Descendant · 2 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
Descendant · 2 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2003high 8 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 61 · See all

K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · cites it directly59descendants
K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · cites it directly47descendants
K023553Mastergraft MatrixMedtronic Sofamor Danek, Inc. · 2003 · cites it directly39descendants
K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 2 generations on38descendants
K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012506	Mastergraft Resorbable Ceramic Granules	Medtronic Sofamor Danek USA, Inc.	2002	—
+1	K051386	Mastergraft Putty Bone Void Filler	Medtronic Vascular	2005	—
+1	K071813	Mastergraft Putty	Medtronic Sofamor Danek	2007	—
+1	K023553	Mastergraft Matrix	Medtronic Sofamor Danek, Inc.	2003	—
+2	K082166	Mastergraft Strip	Medtronic Sofamor Danek	2009	—
+2	K140375	Mastergraft Putty, Mastergraft Strip	Medtronic Sofamor Danek USA, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2007	3	0
2008	3	0
2009	2	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	4	0
2015	1	0
2016	1	0
2017	2	0
2018	3	0
2019	3	0
2020	6	0
2021	1	0
2022	5	0
2023	8	0
2024	8	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K012506, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQV device

#1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (61)

See all 61

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051386	Mastergraft Putty Bone Void Filler	Medtronic Vascular	2005	59
K071813	Mastergraft Putty	Medtronic Sofamor Danek	2007	47
K023553	Mastergraft Matrix	Medtronic Sofamor Danek, Inc.	2003	39
K071187	Microfuse Bone Void Filler	Globus Medical, Inc.	2007	4

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K051386 (Medtronic Vascular, 2005) has gone furthest, with 59 descendants of its own.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	144	5	67
2008	32	102	3	71
2009	23	180	1	81
2010	17	147	0	68
2011	16	92	6	114
2012	9	107	3	149
2013	12	197	2	223
2014	20	153	0	111
2015	18	184	0	125
2016	8	214	1	106
2017	17	124	1	107
2018	23	124	2	86
2019	13	90	0	65
2020	15	132	1	126
2021	8	88	0	101
2022	9	118	0	47
2023	21	74	3	120
2024	28	55	2	68
2025	14	57	1	57
2026	5	96	4	—

What is it indicated for?

MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012506 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012506: Mastergraft Resorbable Ceramic Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012506

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026