510(k) · Cleared
Recalled · Class II · 2013Microfuse Putty and Microfuse ST Mis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 22, 2010 as substantially equivalent to K071187 (Globus Medical, Inc., 2007) and 2 other predicates after a 121-day review. Its family tree reaches back 10 generations to 1996. It has been recalled once.
- Decided
- Dec 22, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K960978 (1996). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK071187 Microfuse Bone Void FillerGlobus Medical, Inc. · 2007
- 2 generations backK082442 Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- 1 generation backK083232 Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- This deviceK102392 Microfuse Putty and Microfuse ST MisGlobus Medical, Inc. · 2010
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 7 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 6 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 5 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 4 generations backK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
- 3 generations backK071187 Microfuse Bone Void FillerGlobus Medical, Inc. · 2007
- 2 generations backK082442 Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- 1 generation backK083232 Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- This deviceK102392 Microfuse Putty and Microfuse ST MisGlobus Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −7 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −6 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −5 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −4 | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
| −3 | K071187 | Microfuse Bone Void Filler | Globus Medical, Inc. | 2007 | — |
| −2 | K082442 | Modification to Microfuse Bone Void Filler | Globus Medical, Inc. | 2008 | — |
| −1 | K083232 | Modification to:Microfuse Bone Void Filler | Globus Medical, Inc. | 2008 | — |
| 0 (this device) | K102392 | Microfuse Putty and Microfuse ST Mis | Globus Medical, Inc. | 2010 | — |
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 |
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
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 | Decided |
|---|---|---|---|
| * | K071187 | Microfuse Bone Void FillerSummary page 1…um Salt Bone Void, Filler Product Code is MQV Regulatory Class 11Panel Code 87. Predicate(s): MicroFuse® Bone Void Filler (K071187, K082442 and K083232) Purpose: The purpose of this submission is to add MicroFuse® additional implants (Putt… | 2007 |
| * | K082442 | Modification to Microfuse Bone Void FillerSummary page 1…one Void, Filler Product Code is MQV Regulatory Class 11Panel Code 87. Predicate(s): MicroFuse® Bone Void Filler (K071187, K082442 and K083232) Purpose: The purpose of this submission is to add MicroFuse® additional implants (Putty and ST… | 2008 |
| * | K083232 | Modification to:Microfuse Bone Void FillerSummary page 1…Product Code is MQV Regulatory Class 11Panel Code 87. Predicate(s): MicroFuse® Bone Void Filler (K071187, K082442 and K083232) Purpose: The purpose of this submission is to add MicroFuse® additional implants (Putty and ST MIS) to the MicroFuse® product l… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2013 | Class II | Z-0123-2014 | Process control | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K071187.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 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® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse® Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse® 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/K102392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102392: Microfuse Putty and Microfuse ST Mis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102392
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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