510(k) · Cleared
ClearedWright Plaster of Paris Pellets (Subject to Revision)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound
Cleared on Jun 21, 1996 after a 102-day review. The FDA summary names its predicate without a number. 320 later devices descend from it.
- Decided
- Jun 21, 1996
- Review
- 102 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
320 later devices descend from it, 2 citing it directly.
- This deviceK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- Descendant · cites it directly · 312 of its ownK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- Descendant · 2 generations on · 162 of its ownK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- Descendant · 2 generations on · 133 of its ownK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- Descendant · 3 generations on · 123 of its ownK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- Descendant · 3 generations on · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
Showing 5 of 320 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 320 · See all- K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Interpore Intl. · 1998 · cites it directly312descendants
- K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002 · 2 generations on162descendants
- K030131Ossatura BCP Bone Void FillerIsotis NV · 2003 · 2 generations on133descendants
- K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005 · 3 generations on123descendants
- K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · 3 generations on120descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| +1 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| +2 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| +2 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| +3 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| +3 | K060728 | Novabone Putty - Bioactive Synthetic Graft | Novabone Products, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 20 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 11 | 0 |
| 2011 | 15 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 17 | 0 |
| 2015 | 13 | 0 |
| 2016 | 5 | 0 |
| 2017 | 15 | 0 |
| 2018 | 11 | 0 |
| 2019 | 9 | 0 |
| 2020 | 12 | 0 |
| 2021 | 4 | 0 |
| 2022 | 11 | 0 |
| 2023 | 22 | 0 |
| 2024 | 33 | 0 |
| 2025 | 21 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | — | Plaster of Paris Pellets (Ethicon) Named without a submission number |
What descends from it? (320)
See all 3202 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?
- Of its descendants, K980817 (Interpore Intl., 1998) has gone furthest, with 312 descendants of its own.
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?
Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing long bone voids. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Wright Plaster of Paris Pellets provide a bone filler that resorbs and is replaced with bone during the 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/K960978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960978: Wright Plaster of Paris Pellets (Subject to Revision).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960978
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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