510(k) · Cleared
Recalled · Class II · 2025Bi-Ostetic Bioactive Glass Foam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Berkeley Advanced Biomaterials · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 30, 2017 as substantially equivalent to K050789 (R and D Medical, LLC, 2005) and 1 other predicate after a 215-day review. Its family tree reaches back 5 generations to 1996. It has been recalled once.
- Decided
- Oct 30, 2017
- Review
- 215 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960978 (1996). 14 ancestors in all. No later device cites it as a predicate yet.
- 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 backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 2 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 1 generation backK050789 Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005
- This deviceK170917 Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials · 2017
View 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 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −2 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −1 | K050789 | Formagraft Collagen Bone Graft Matrix | R and D Medical, LLC | 2005 | — |
| 0 (this device) | K170917 | Bi-Ostetic Bioactive Glass Foam | Berkeley Advanced Biomaterials | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K050789 | Formagraft Collagen Bone Graft MatrixSummary page 5…tetic Foam (K092046) in which part of the HA- TCP granules has been substituted with 45S5 granules. Bi-Ostetic BGF Foam is also similar in characteristics to FormaGraft (K050789). The radiographic, morphometric and histologic performance of the device was compared to that of the predicate. E. PERFORMANCE… | 2005 |
| * | K092046 | BI-Ostetic Foam and Putty, Generos Foam and PuttySummary page 5…cal properties were evaluated by Scanning Electron Microscopy (SEM). Sterilization is performed according to ISO 11137 standards. Bi-Ostetic BGF Foam is Bi-Ostetic Foam (K092046) in which part of the HA- TCP granules has been substituted with 45S5 granules. Bi-Ostetic BGF Foam is also similar in characteri… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2025 | Class II | Z-0540-2026 | Process control | Due to incorrect product label (Incorrect product name identified on outer packaging). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K050789.
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. 2017, 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?
Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone, and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170917: Bi-Ostetic Bioactive Glass Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170917
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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