510(k) · Cleared
ClearedFormagraft Collagen Bone Graft Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R and D Medical, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on May 27, 2005 as substantially equivalent to K012751 (Orquest, Inc., 2001) and 3 other predicates after a 60-day review. Its family tree reaches back 4 generations to 1996. 11 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K960978 (1996). 12 ancestors in all. 11 later devices descend from it, 3 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 deviceK050789 Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005
- Descendant · cites it directly · 7 of its ownK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
- Descendant · 2 generations on · 4 of its ownK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
- Descendant · 3 generations on · 3 of its ownK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- Descendant · 4 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · 5 generations on · 1 of its ownK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009 · cites it directly7descendants
- K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011 · 2 generations on4descendants
- K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 3 generations on3descendants
- K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017 · 4 generations on2descendants
- K242797OsteoFlo HydroFiberSurGenTec, LLC · 2024 · 5 generations on1descendant
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) | K050789 | Formagraft Collagen Bone Graft Matrix | R and D Medical, LLC | 2005 | — |
| +1 | K091031 | Pioneer Surgical Nanoss BVF-E | Pioneer Surgical Technology | 2009 | — |
| +2 | K110561 | Fortross Bone Void Filler | Pioneer Surgical Technology | 2011 | — |
| +3 | K141600 | Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
| +4 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +5 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
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 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (4)
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 2…cteristics of Formagraft Collagen Bone Graft Matrix and the predicate devices are substantially the same. These devices include Orquest, Inc. Healos Bone Graft Material (K012751); NeuColl, Inc. Collagrafi Strip Bone Graft Matrix (K000122); Berkeley Advanced Biomaterials Inc. Bi-Ostetic (K023703) and Orthov… | 2001 |
| * | K000122 | Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6…Summary page 2…predicate devices are substantially the same. These devices include Orquest, Inc. Healos Bone Graft Material (K012751); NeuColl, Inc. Collagrafi Strip Bone Graft Matrix (K000122); Berkeley Advanced Biomaterials Inc. Bi-Ostetic (K023703) and Orthovita Vitoss Scaffold Foam (K032288). These devices all are in… | 2001 |
| * | K023703 | BI-OsteticSummary page 2…s include Orquest, Inc. Healos Bone Graft Material (K012751); NeuColl, Inc. Collagrafi Strip Bone Graft Matrix (K000122); Berkeley Advanced Biomaterials Inc. Bi-Ostetic (K023703) and Orthovita Vitoss Scaffold Foam (K032288). These devices all are intended to fill voids or gaps in osseous defects, are not i… | 2003 |
| * | K032288 | Vitoss Scaffold Foam Bone Graft MaterialSummary page 2…erial (K012751); NeuColl, Inc. Collagrafi Strip Bone Graft Matrix (K000122); Berkeley Advanced Biomaterials Inc. Bi-Ostetic (K023703) and Orthovita Vitoss Scaffold Foam (K032288). These devices all are intended to fill voids or gaps in osseous defects, are not intended to be load-bearing and consist of a v… | 2003 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 ancestors has a recall of any class.
- Of its descendants, K091031 (Pioneer Surgical Technology, 2009) has gone furthest, with 7 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?
Formagraft TM Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is…
Read the full statement (132 words)
Formagraft TM Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050789: Formagraft Collagen Bone Graft Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050789
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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