510(k) · Cleared

Cleared

Microfuse Bone Void Filler

K071187510(k) TraditionalCleared Dec 20, 2007234-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

Globus Medical, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Dec 20, 2007 as substantially equivalent to K012506 (Medtronic Sofamor Danek USA, Inc., 2002) and 2 other predicates after a 234-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.

Decided: Dec 20, 2007
Review: 234 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 3

Its longest line of descent runs back 7 generations to K960978 (1996). 20 ancestors in all. 4 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
5 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
4 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
3 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
2 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
1 generation backK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
This deviceK071187 Microfuse Bone Void FillerGlobus Medical, Inc. · 2007
Descendant · cites it directly · 2 of its ownK082442 Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
Descendant · cites it directly · 1 of its ownK083232 Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
Descendant · cites it directly · 0 of its ownK102392 Microfuse Putty and Microfuse ST MisGlobus Medical, Inc. · 2010 · Recalled
Descendant · cites it directly · 0 of its ownK083449 E-Matrix Graft Bone ExtenderPioneer Surgical Technology · 2009

Most influential descendants

Showing 4 of 4 · See all

K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008 · cites it directly2descendants
K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008 · cites it directly1descendant
K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc. · 2010 · cites it directly0descendants
K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K960978	Wright Plaster of Paris Pellets (Subject to Revision)	Wrightmedicaltechnologyinc	1996	—
−6	K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…	Interpore Intl.	1998	—
−5	K000515	Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101…	Interpore Cross Intl.	2000	—
−4	K012751	Healos Bone Graft Material	Orquest, Inc.	2001	—
−3	K043308	Modification to: Healos Bone Graft Material	Depuy Spine, Inc.	2005	—
−2	K051386	Mastergraft Putty Bone Void Filler	Medtronic Vascular	2005	—
−1	K060917	Kensey Nash Bone Void Filler	Kensey Nash Corporation	2006	—
0 (this device)	K071187	Microfuse Bone Void Filler	Globus Medical, Inc.	2007	—
+1	K082442	Modification to Microfuse Bone Void Filler	Globus Medical, Inc.	2008	—
+1	K083232	Modification to:Microfuse Bone Void Filler	Globus Medical, Inc.	2008	—
+1	K102392	Microfuse Putty and Microfuse ST Mis	Globus Medical, Inc.	2010	1
+1	K083449	E-Matrix Graft Bone Extender	Pioneer Surgical Technology	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	2	0
2002	2	0
2003	2	0
2004	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K071187, 1996–2010Source: 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? (3)

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
*	K012506	Mastergraft Resorbable Ceramic Granules Summary page 1 …FR §888.3045: Resorbable Calcium Salt Bone Void Filler. Class II. The Product Code is MQV. The Panel Code is 87. PREDICATE DEVICES: Medtronic Sofamor Danek MasterGraft K012506, SE date March 7, 2002; OsteoBiologics PolyGraft BGS K040047, SE date Dec 17, 2004; and Kensey Nash Bone Void Filler K060917, SE…	Medtronic Sofamor Danek USA, Inc.	2002	—
*	K040047	Polygraft BGS; Bone Graft Substitute Summary page 1 …II. The Product Code is MQV. The Panel Code is 87. PREDICATE DEVICES: Medtronic Sofamor Danek MasterGraft K012506, SE date March 7, 2002; OsteoBiologics PolyGraft BGS K040047, SE date Dec 17, 2004; and Kensey Nash Bone Void Filler K060917, SE date Sept 22, 2006. DEVICE DESCRIPTION: MicroFuseTM Bone Vo…	Osteobiologics, Inc.	2004	1
*	K060917	Kensey Nash Bone Void Filler Summary page 1 …EVICES: Medtronic Sofamor Danek MasterGraft K012506, SE date March 7, 2002; OsteoBiologics PolyGraft BGS K040047, SE date Dec 17, 2004; and Kensey Nash Bone Void Filler K060917, SE date Sept 22, 2006. DEVICE DESCRIPTION: MicroFuseTM Bone Void Filler is a porous bone graft scaffold composed of bonded pol…	Kensey Nash Corporation	2006	—

Also cleared against K012506: 3 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K082442	Modification to Microfuse Bone Void Filler	Globus Medical, Inc.	2008	2
K083232	Modification to:Microfuse Bone Void Filler	Globus Medical, Inc.	2008	1
K102392	Microfuse Putty and Microfuse ST Mis	Globus Medical, Inc.	2010	0
K083449	E-Matrix Graft Bone Extender	Pioneer Surgical Technology	2009	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?

The line of descent spans 11 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
2 of the 20 ancestors have a recall of any class.
Of its descendants, K082442 (Globus Medical, Inc., 2008) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K012506.

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. 2007, this device’s year, is highlighted.

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?

MicroFuse TM Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuseTM 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/K071187 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071187: Microfuse Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071187

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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