510(k) · Cleared
ClearedSorrento Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haider Biologics, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 23, 2015 as substantially equivalent to K032288 (Orthovita, Inc., 2003) after a 269-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Feb 23, 2015
- Review
- 269 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032288 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032288 Vitoss Scaffold Foam Bone Graft MaterialOrthovita, Inc. · 2003
- This deviceK141429 Sorrento Bone Graft SubstituteHaider Biologics, LLC · 2015
- Descendant · cites it directly · 0 of its ownK191074 Sorrento Bone Graft SubstituteXenco Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK173933 Sorrento Bioglass Bone Graft SubstituteXenco Medical, LLC · 2018
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 |
|---|---|---|---|---|---|
| −1 | K032288 | Vitoss Scaffold Foam Bone Graft Material | Orthovita, Inc. | 2003 | — |
| 0 (this device) | K141429 | Sorrento Bone Graft Substitute | Haider Biologics, LLC | 2015 | — |
| +1 | K191074 | Sorrento Bone Graft Substitute | Xenco Medical, LLC | 2019 | — |
| +1 | K173933 | Sorrento Bioglass Bone Graft Substitute | Xenco Medical, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K032288 | Vitoss Scaffold Foam Bone Graft MaterialSummary page 4…evices: 510(k) # Trade Name Product Code Vitoss® Scaffold Foam Bone Graft Material K032288 MQV (Orthovita, Inc.) Device D… | 2003 |
What descends from it? (2)
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. 2015, 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?
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141429: Sorrento Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141429
Report an extraction error
Are you the manufacturer?
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