510(k) · Cleared
ClearedBonesave Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 9, 2004 as substantially equivalent to K991854 (Interpore Cross Intl., 1999) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 152 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963587 (1997). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- 1 generation backK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
- This deviceK033258 Bonesave Bone Void FillerHowmedica Osteonics · 2004
- Descendant · cites it directly · 0 of its ownK063157 Merries K-Phate Bone Graft SubstituteMerries International, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK071121 Tribone 80Biomatlante · 2007
- Descendant · cites it directly · 0 of its ownK063527 MBCP+Biomatlante · 2007 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| −1 | K991854 | Osteoplast, Model POP200 | Interpore Cross Intl. | 1999 | — |
| 0 (this device) | K033258 | Bonesave Bone Void Filler | Howmedica Osteonics | 2004 | — |
| +1 | K063157 | Merries K-Phate Bone Graft Substitute | Merries International, Inc. | 2008 | — |
| +1 | K071121 | Tribone 80 | Biomatlante | 2007 | — |
| +1 | K063527 | MBCP+ | Biomatlante | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K991854 | Osteoplast, Model POP200Summary page 1…Product Code: MQV - Filler, Calcium Sulfate, Preformed Pellet Predicate Proprietary Name(s): K991 854: Osteoplast Bone Void Filler Pellets (Interpore Cross International)… | 1999 |
| * | K020986 | Mastergraft Resorbable CeramicSummary page 1…K991 854: Osteoplast Bone Void Filler Pellets (Interpore Cross International) K020986: MastergraftTm Resorbable Ceramic Pellets (Medtronic Sofamor Danek… | 2002 |
What descends from it? (3)
3 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 7 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063157 (Merries International, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K991854.
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?
BoneSaveTM Calcium phosphate granules (20cc) are indicated for osseous defect filling of bones not intrinsic to stability of the bony structure.
BoneSaveTM Calcium phosphate granules are indicated to be gently packed into osseous defects (i.e. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033258 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033258: Bonesave Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033258
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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