510(k) · Cleared
ClearedWright Plaster of Paris Bone Void Filler Kit (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 Mar 24, 1997 after a 196-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Mar 24, 1997
- Review
- 196 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- Descendant · cites it directly · 9 of its ownK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
- Descendant · cites it directly · 6 of its ownK013790 Calcigen-S Bone Void FilerBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK031319 Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK033258 Bonesave Bone Void FillerHowmedica Osteonics · 2004
- Descendant · 2 generations on · 1 of its ownK091688 A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K991854Osteoplast, Model POP200Interpore Cross Intl. · 1999 · cites it directly9descendants
- K013790Calcigen-S Bone Void FilerBiomet Orthopedics, Inc. · 2002 · cites it directly6descendants
- K031319Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003 · cites it directly4descendants
- K033258Bonesave Bone Void FillerHowmedica Osteonics · 2004 · 2 generations on3descendants
- K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| +1 | K991854 | Osteoplast, Model POP200 | Interpore Cross Intl. | 1999 | — |
| +1 | K013790 | Calcigen-S Bone Void Filer | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K031319 | Osteo-G Bone Void Filler System | Aspine USA, Inc. | 2003 | — |
| +2 | K033258 | Bonesave Bone Void Filler | Howmedica Osteonics | 2004 | — |
| +2 | K091688 | A-Grix Resorbable Bone Void Filler | Ag Digital Technology Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Wright Plaster of Paris Pellets Named without a submission number |
What descends from it? (13)
See all 134 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, K991854 (Interpore Cross Intl., 1999) has gone furthest, with 9 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 voids in long bone. These bone voids may be surgically created osseous defects or osseous defects created from traumatic, injury to the bone. The pellets provide a bone void 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/K963587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963587: Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963587
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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