510(k) · Cleared
ClearedHealos Bone Graft Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orquest, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 14, 2001 as substantially equivalent to K994337 (Orthovita Co., 2000) and 6 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1996. 84 later devices descend from it.
- Decided
- Nov 14, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K960978 (1996). 9 ancestors in all. 84 later devices descend from it, 11 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- This deviceK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- Descendant · cites it directly · 67 of its ownK043308 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 · 54 of its ownK033679 Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
- Descendant · cites it directly · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 40 of its ownK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005 · cites it directly67descendants
- K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · cites it directly59descendants
- K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004 · cites it directly54descendants
- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · cites it directly47descendants
- K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006 · cites it directly40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| 0 (this device) | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| +1 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| +1 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| +1 | K033679 | Copsios Bone Void Filler (BVF) | Centerpulse Spine-Tech, Inc. | 2004 | — |
| +1 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| +1 | K052812 | Ossimend (TM) Bone Graft Material | Collagen Matrix, Inc. | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 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? (7)
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 |
|---|---|---|---|
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…name: Bone void filler Product code (classification): MQYV (not classified) Legally Marketed Predicate Devices: Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337); Pro Osteon Implant 500R Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K99013… | 2000 |
| * | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Summary page 1…Scaffold Synthetic Cancellous Bone Void Filler (K994337); Pro Osteon Implant 500R Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matri… | 1998 |
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 1…Synthetic Cancellous Bone Void Filler (K994337); Pro Osteon Implant 500R Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matrix (K00012… | 1999 |
| * | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201…Summary page 2…and legally marketed predicate devices named in the chart below as follows. . HEALOS and the predicate devices, Vitoss (K9943 37) and Pro Osteon (K980817, K990131, and K000515) are intended for the same use and target populations. . HEALOS and the predicate devices are sterile and are all matrices that… | 2000 |
| * | K974399 | Bio-Oss CollagenSummary page 1…K994337); Pro Osteon Implant 500R Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matrix (K000122) Device Description: HEALOS® Bone G… | 1998 |
| * | K003339 | Collagen Periodontal MembraneSummary page 1…Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matrix (K000122) Device Description: HEALOS® Bone Graft Material (HEALOS) is a mineralized collag… | 2001 |
| * | K000122 | Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6… Cleared while this submission was under review Summary page 1…sorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matrix (K000122) Device Description: HEALOS® Bone Graft Material (HEALOS) is a mineralized collagen matrix processed into lyophilized strips or… | 2001 |
What descends from it? (84)
See all 8411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043308 | Modification to: Healos Bone Graft Material | 2005 | 67 |
| K051386 | Mastergraft Putty Bone Void Filler | 2005 | 59 |
| K033679 | Copsios Bone Void Filler (BVF) | 2004 | 54 |
| K071813 | Mastergraft Putty | 2007 | 47 |
| K052812 | Ossimend (TM) Bone Graft Material | 2006 | 40 |
| K050789 | Formagraft Collagen Bone Graft Matrix | 2005 | 11 |
| K081432 | Healos II Bone Graft Substitute | 2008 | 3 |
| K141725 | Bongold Bone Graft Material | 2015 | 1 |
| 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 |
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 5 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K043308 (Depuy Spine, Inc., 2005) has gone furthest, with 67 descendants of its own.
- 25 other devices also cite its predicate K994337.
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 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/K012751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012751: 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/K012751
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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