510(k) · Cleared

Cleared

Mastergraft Resorbable Ceramic

K020986510(k) TraditionalCleared Jul 22, 2002117-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, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 22, 2002 as substantially equivalent to K990131 (Interpore Cross Intl., 1999) after a 117-day review. Its family tree reaches back 1 generation to 1999. 158 later devices descend from it.

Decided: Jul 22, 2002
Review: 117 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K990131 (1999). 158 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
This deviceK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
Descendant · cites it directly · 142 of its ownK032268 MBCPBiomatlante · 2003
Descendant · 2 generations on · 122 of its ownK043005 Modification to MBCPBiomatlante · 2005
Descendant · 2 generations on · 60 of its ownK051774 MBCPBiomatlante · 2006
Descendant · cites it directly · 59 of its ownK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
Descendant · 2 generations on · 59 of its ownK051885 MBCPBiomatlante · 2005

Showing 5 of 158 descendants. See all descendants

Descendants cleared per year

2003high 13 (2023) · low 1 (2013)2026

Most influential descendants

Showing 5 of 158 · See all

K032268MBCPBiomatlante · 2003 · cites it directly142descendants
K043005Modification to MBCPBiomatlante · 2005 · 2 generations on122descendants
K051774MBCPBiomatlante · 2006 · 2 generations on60descendants
K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · cites it directly59descendants
K051885MBCPBiomatlante · 2005 · 2 generations on59descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute	Interpore Cross Intl.	1999	—
0 (this device)	K020986	Mastergraft Resorbable Ceramic	Medtronic Sofamor Danek, Inc.	2002	—
+1	K032268	MBCP	Biomatlante	2003	—
+2	K043005	Modification to MBCP	Biomatlante	2005	—
+2	K051774	MBCP	Biomatlante	2006	—
+1	K051386	Mastergraft Putty Bone Void Filler	Medtronic Vascular	2005	—
+2	K051885	MBCP	Biomatlante	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	6	0
2006	5	0
2007	10	0
2008	10	0
2009	11	0
2010	7	0
2011	2	0
2012	6	0
2013	1	0
2014	6	0
2015	2	0
2016	2	0
2017	4	0
2018	9	0
2019	5	0
2020	7	0
2021	9	0
2022	10	0
2023	13	0
2024	13	0
2025	9	0
2026	7	0

FIG. 1 — Lineage of K020986, 1999–2026Source: 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

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Summary page 1 …s provided which demonstrated the MasterGraftTMResorbable Ceramic to be substantially equivalent to itself and Interpore Cross Lntemational ProOsteon 500R (K990131). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…	Interpore Cross Intl.	1999	—

Also cleared against K990131: 17 other devices →

What descends from it? (158)

See all 158

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

Number	Device	Applicant	Decided	Descendants
K032268	MBCP	Biomatlante	2003	142
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
K082917	Mastergraft Resorbable Ceramic Granules	Medtronic Sofamor Danek	2009	3
K033258	Bonesave Bone Void Filler	Howmedica Osteonics	2004	3
K082918	Mastergraft Resorbable Ceramic Granules	Medtronic Sofamor Danek	2009	1
K090387	Kainos+	Signus Medizintechnik GmbH	2009	0
K050490	Osmosys Calcium Phosphate Ceramic Bone Filler	Medicrea	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K032268 (Biomatlante, 2003) has gone furthest, with 142 descendants of its own.
17 other devices also cite its predicate K990131.

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?

MasterGraftTM Resorbable Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraftTM Resorbable Ceramic is to be gently packed into bony voids 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 provides a bone void filler that resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020986 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020986: Mastergraft Resorbable Ceramic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020986

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026