510(k) · Cleared
ClearedOsteoplast, Model POP200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 26, 1999 as substantially equivalent to K963587 (Wrightmedicaltechnologyinc, 1997) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- Aug 26, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963587 (1997). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- This deviceK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
- Descendant · cites it directly · 4 of its ownK031319 Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 0 of its ownK121453 A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK072444 Wellgraft PE IGwowei Technology Co., Ltd. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K031319Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003 · cites it directly4descendants
- K033258Bonesave Bone Void FillerHowmedica Osteonics · 2004 · cites it directly3descendants
- K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010 · 2 generations on1descendant
- K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013 · 3 generations on0descendants
- K072444Wellgraft PE IGwowei Technology Co., Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| 0 (this device) | K991854 | Osteoplast, Model POP200 | Interpore Cross Intl. | 1999 | — |
| +1 | K031319 | Osteo-G Bone Void Filler System | Aspine USA, Inc. | 2003 | — |
| +1 | K033258 | Bonesave Bone Void Filler | Howmedica Osteonics | 2004 | — |
| +2 | K091688 | A-Grix Resorbable Bone Void Filler | Ag Digital Technology Corp. | 2010 | — |
| +3 | K121453 | A-Grix TE Resorable Bone Void Filler | Ag Digital Technology Corp. | 2013 | — |
| +2 | K072444 | Wellgraft PE I | Gwowei Technology Co., Ltd. | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Summary page 1…Graft Substitute Product Classification: Unclassified Proprietary Name: Osteoplast Bone Void Filler PREDICATE DEVICE Wright Medical’s OsteoSet Bone Void Filler 510(k) K963587 and 510(k) K963562. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requir… | 1997 |
| * | K963562 | Wright Plaster of Paris PelletsSummary page 1…oduct Classification: Unclassified Proprietary Name: Osteoplast Bone Void Filler PREDICATE DEVICE Wright Medical’s OsteoSet Bone Void Filler 510(k) K963587 and 510(k) K963562. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §8… | 1997 |
What descends from it? (9)
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?
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?
Osteoplast Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteoplast Pellets are indicated 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 Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, it may be used at an infected site.
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/K991854 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991854: Osteoplast, Model POP200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991854
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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