510(k) · Cleared
ClearedCellplex TCP Synthetic Cancellous Bone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 17, 2003 as substantially equivalent to K022629 (Wrightmedicaltechnologyinc, 2002) and 1 other predicate after a 35-day review. Its family tree reaches back 2 generations to 2002. 52 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013966 (2002). 3 ancestors in all, the oldest K994337 (2000). 52 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 1 generation backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- This deviceK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- Descendant · cites it directly · 51 of its ownK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- Descendant · 2 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- Descendant · 3 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- Descendant · 4 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- Descendant · 2 generations on · 37 of its ownK062986 Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · cites it directly51descendants
- K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 2 generations on45descendants
- K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 3 generations on41descendants
- K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 4 generations on40descendants
- K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −1 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| 0 (this device) | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| +1 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| +2 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| +3 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| +4 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| +2 | K062986 | Medtronic Graft Delivery Syringe | Medtronic Sofamor Danek USA, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K022629 | WMT-TCP Bone Graft SubstituteSummary page 2…Cancellous Bone are substantially equivalent to the intended use, material composition, and design features of the previously cleared WMT-TCP Bone Graft Substitute (K022629). The mechanical properties of the CELLPLEXTMTCP Synthetic Cancellous Bone are substantially equivalent to the VITOSSTMScaffold… | 2002 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 2…The mechanical properties of the CELLPLEXTMTCP Synthetic Cancellous Bone are substantially equivalent to the VITOSSTMScaffold Synthetic Cancellous Bone Void Filler (K994337). The safety and effectiveness of the CELLPLEXTMTCP Synthetic Cancellous Bone is adequately supported by the substantial equiva… | 2000 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043261 | Harvest Graft Delivery Syringe | 2005 | 51 |
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 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K043261 (Harvest Technologies, Corp., 2005) has gone furthest, with 51 descendants of its own.
- 2 other devices also cite its predicate K022629.
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?
CELLPLEXTMTCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEXTMTCP Synthetic Cancellous Bone is intended to be gently packed into 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. The product resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031817: Cellplex TCP Synthetic Cancellous Bone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031817
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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