510(k) · Cleared
ClearedOsteocrete Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bone Solutions, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on May 21, 2009 as substantially equivalent to K011897 (Synthes (Usa), 2001) and 3 other predicates after a 773-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- May 21, 2009
- Review
- 773 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K960978 (1996). 19 ancestors in all, the oldest K910432 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 2 generations backK033722 Apapore Bone Graft SubstituteApatech, Ltd. · 2004
- 1 generation backK051951 Cerament Bone Void FillerBonesupport AB · 2005
- This deviceK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK212991 OsteoreviveBone Solutions, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK221256 Mg OSTEOINJECTBone Solutions, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −2 | K033722 | Apapore Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −1 | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| 0 (this device) | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
| +1 | K212991 | Osteorevive | Bone Solutions, Inc. | 2022 | — |
| +2 | K221256 | Mg OSTEOINJECT | Bone Solutions, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K011897 | Norian SRS Bone Void FillerSummary page 1…lassification: Class II, MQV, 21 CFR 888.3045 Predicate Devices: Synthes (USA). Norian SRS Bone Void Filler, 51O(k) number K011897 Synthes (USA). Norian SRS Fast Set Putty, 510(k) number K041842… | 2001 |
| * | K041842 | Norian SRS Fast Set PuttySummary page 1…id Filler, 51O(k) number K011897 Synthes (USA). Norian SRS Fast Set Putty, 510(k) number K041842 FuturaBiomedical. OsteoCure Resorbable Bead Kit, 510(k) number K051406… | 2004 |
| * | K051406 | Osteocure Resorbable Bead KitSummary page 1…ty, 510(k) number K041842 FuturaBiomedical. OsteoCure Resorbable Bead Kit, 510(k) number K051406 Bone Support AB. Cerament Bone Void Filler, 510(k) number K051951 Device D… | 2005 |
| * | K051951 | Cerament Bone Void FillerSummary page 1…ead Kit, 510(k) number K051406 Bone Support AB. Cerament Bone Void Filler, 510(k) number K051951 Device Description: OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Fill… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212991 | Osteorevive | 2022 | 1 |
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 13 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K212991 (Bone Solutions, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K011897.
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. 2009, this device’s year, is highlighted.
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?
Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone 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. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071004: Osteocrete Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071004
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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