510(k) · Cleared
ClearedCopsios Bone Void Filler (BVF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerpulse Spine-Tech, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 7, 2004 as substantially equivalent to K012751 (Orquest, Inc., 2001) and 5 other predicates after a 226-day review. Its family tree reaches back 4 generations to 1996. 54 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 226 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K960978 (1996). 10 ancestors in all. 54 later devices descend from it, 4 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 deviceK033679 Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
- Descendant · cites it directly · 40 of its ownK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
- Descendant · 2 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- Descendant · 3 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
- Descendant · 4 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006 · cites it directly40descendants
- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 2 generations on38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 3 generations on30descendants
- K060917Kensey Nash Bone Void FillerKensey Nash Corporation · 2006 · cites it directly7descendants
- K181225AltaporeBaxter Healthcare Corporation · 2018 · 4 generations on6descendants
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) | K033679 | Copsios Bone Void Filler (BVF) | Centerpulse Spine-Tech, Inc. | 2004 | — |
| +1 | K052812 | Ossimend (TM) Bone Graft Material | Collagen Matrix, Inc. | 2006 | — |
| +2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +3 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
| +4 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012751 | Healos Bone Graft MaterialSummary page 1…Void Filler Classification Number: Class IL Product Code: 89MQV Legally Marketed Predicate Devices: HEALOS Bone Graft Material (K012751); Collagraft Strip Bone Graft Matrix (KO0122); Vitoss Scaffold Sy… | 2001 |
| Kept off the family tree | K000122 | FDA’s K000122 is Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…Collagraft Strip Bone Graft Matrix (KO0122); Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337); Pro Osteon Implant 50OR Resorbable Bone Graft Filler/Bone Graft… | 2000 |
| * | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Summary page 1…Osteon Implant 50OR Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399) Device Descriptio… | 1998 |
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 1…plant 50OR Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399) Device Description: CopiO… | 1999 |
| * | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201…Summary page 1…Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399) Device Description: CopiOsTM BVF is a synthetic bone graft materia… | 2000 |
| * | K974399 | Bio-Oss CollagenSummary page 1…Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399) Device Description: CopiOsTM BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has b… | 1998 |
| * | — | Pro Osteon Implant 50OR Resorbable Bone Graft Filler/Bone Graft Material; 200R… Named without a submission number |
What descends from it? (54)
See all 544 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 8 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, K052812 (Collagen Matrix, Inc., 2006) has gone furthest, with 40 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?
CopiOsTM BVF, in combination with autologous bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e., extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOsTM BVF is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033679: Copsios Bone Void Filler (BVF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033679
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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