510(k) · Cleared
ClearedGranOSTM - beta tricalcium phosphate synthetic bone granules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tcm Associates, Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 21, 2015 as substantially equivalent to K041616 (Orthos (Uk) Limited, 2004) and 2 other predicates after a 240-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Aug 21, 2015
- Review
- 240 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K013072 (2002). 4 ancestors in all, the oldest K014156 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK013072 Chronos Tricalcium Prosphate (Chronos TCP)Synthes · 2002
- 2 generations backK032409 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc. · 2003
- 1 generation backK041616 Bgran Synthetic Osteoconductive ScaffoidOrthos (Uk) Limited · 2004
- This deviceK143692 GranOSTM - beta tricalcium phosphate synthetic bone granulesTcm Associates, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013072 | Chronos Tricalcium Prosphate (Chronos TCP) | Synthes | 2002 | — |
| −2 | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita, Inc. | 2003 | — |
| −1 | K041616 | Bgran Synthetic Osteoconductive Scaffoid | Orthos (Uk) Limited | 2004 | — |
| 0 (this device) | K143692 | GranOSTM - beta tricalcium phosphate synthetic bone granules | Tcm Associates, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K041616 | Bgran Synthetic Osteoconductive ScaffoidSummary page 5…pecial Controls as per 21 CFR 888.3045 Device Product Code MQV ® Legally Marketed βGran Synthetic Osteoconductive Scaffold (K041616) ® Predicate Devices Cerasorb ORTHO (K014156) ®… | 2004 |
| * | K014156 | Cerasorb OrthoSummary page 5…® Legally Marketed βGran Synthetic Osteoconductive Scaffold (K041616) ® Predicate Devices Cerasorb ORTHO (K014156) ® Vitoss Scaffold Synthetic Cancellous Bone Void Filler K032409 Device… | 2002 |
| * | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 5…® Predicate Devices Cerasorb ORTHO (K014156) ® Vitoss Scaffold Synthetic Cancellous Bone Void Filler K032409 Device Description GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K041616.
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?
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine 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.
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/K143692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143692: GranOSTM - beta tricalcium phosphate synthetic bone granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143692
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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