510(k) · Cleared
ClearedPolygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteobiologics, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 16, 2004 as substantially equivalent to K030288 (Osteobiologics, Inc., 2003) after a 264-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it.
- Decided
- Aug 16, 2004
- Review
- 264 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960978 (1996). 4 ancestors in all. 10 later devices descend from it, 2 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 backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
- This deviceK033707 Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models…Osteobiologics, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
- Descendant · 2 generations on · 4 of its ownK071187 Microfuse Bone Void FillerGlobus Medical, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK082442 Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK142463 Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK083232 Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K060917Kensey Nash Bone Void FillerKensey Nash Corporation · 2006 · cites it directly7descendants
- K071187Microfuse Bone Void FillerGlobus Medical, Inc. · 2007 · 2 generations on4descendants
- K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008 · 3 generations on2descendants
- K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc. · 2014 · cites it directly1descendant
- K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008 · 3 generations on1descendant
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 | K030288 | Polygraft Bone Graft Substitute | Osteobiologics, Inc. | 2003 | — |
| 0 (this device) | K033707 | Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX… | Osteobiologics, Inc. | 2004 | — |
| +1 | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
| +2 | K071187 | Microfuse Bone Void Filler | Globus Medical, Inc. | 2007 | — |
| +3 | K082442 | Modification to Microfuse Bone Void Filler | Globus Medical, Inc. | 2008 | — |
| +1 | K142463 | Bio2 CLM BG Bioactive Scaffold | Bio2 Technologies, Inc. | 2014 | — |
| +3 | K083232 | Modification to:Microfuse Bone Void Filler | Globus Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K030288 | Polygraft Bone Graft SubstituteSummary page 1…ring the healing process. Substantial Equivalence: The PolyGraftTM TCP is substantially equivalent in design, function and intended use to the PolyGraftTM BGS cleared as K030288 on July 17, 2003. Testing: Biocompatibility assessment performed by independent certified laboratories demonstrated the biocom… | 2003 |
What descends from it? (10)
2 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 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060917 (Kensey Nash Corporation, 2006) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K030288.
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?
The PolyGraftTM TCP is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraftTM TCP is intended to 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 with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033707 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033707: Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033707
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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