510(k) · Cleared
ClearedModification to: Healos Bone Graft Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 16, 2005 as substantially equivalent to K012751 (Orquest, Inc., 2001) after a 77-day review. Its family tree reaches back 4 generations to 1996. 67 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960978 (1996). 10 ancestors in all. 67 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 1 generation backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- This deviceK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 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 · 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
- Descendant · 2 generations on · 7 of its ownK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · cites it directly59descendants
- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · cites it directly47descendants
- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 2 generations on38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on30descendants
- K060917Kensey Nash Bone Void FillerKensey Nash Corporation · 2006 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −1 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| 0 (this device) | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| +1 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| +1 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| +2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +2 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +2 | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K012751 | Healos Bone Graft MaterialSummary page 1…ASSIFICATION NAME: Filler, calcium sulfate preformed pellets PROPRIETARY NAME: HEALOS Bone Graft Material PREDICATE DEVICES: HEALOS Bone Graft Material (K012751) DEVICE DESCRIPTION: Addition of dimensional and volumetric configurations to the HEALOS Bone Gra… | 2001 |
What descends from it? (67)
See all 676 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051386 | Mastergraft Putty Bone Void Filler | 2005 | 59 |
| K071813 | Mastergraft Putty | 2007 | 47 |
| K081432 | Healos II Bone Graft Substitute | 2008 | 3 |
| K062495 | Healos FX Bone Graft Substitute and Graft Mixing and Delivery System | 2006 | 1 |
| K081758 | Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010… | 2008 | 0 |
| K051047 | Colloss E Bone Void Filler | 2006 | 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 9 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K051386 (Medtronic Vascular, 2005) has gone furthest, with 59 descendants of its own.
- 10 other devices also cite its predicate K012751.
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.
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?
HEALOS Bone Graft Material ("HEALOS"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043308: Modification to: Healos Bone Graft Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043308
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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