510(k) · Cleared
ClearedTripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthogem Limited · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 21, 2011 as substantially equivalent to K070132 (Orthogem Limited, 2007) and 1 other predicate after a 31-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.
- Decided
- Apr 21, 2011
- Review
- 31 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K013966 (2002). 17 ancestors in all, the oldest K994337 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 4 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 3 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 2 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 1 generation backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- This deviceK110787 Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited · 2011
- Descendant · cites it directly · 0 of its ownK150064 Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −4 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −3 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −2 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −1 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| 0 (this device) | K110787 | Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15) | Orthogem Limited | 2011 | — |
| +1 | K150064 | Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) | Orthogem, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K070132 | Tripore, Models HA, BP90, BP15Summary page 1…ass 11Special Control per 21 CFR 888.3045. Product code: MQV Predicate Devices (1)TriPore Calcium Phosphate granules K070132 (2) FibriJet@ Graft Delivery Device K100754 Device Description TniPore TDD is… | 2007 |
| * | K100754 | Graft Delivery System Model SA-6115Summary page 1…oduct code: MQV Predicate Devices (1)TriPore Calcium Phosphate granules K070132 (2) FibriJet@ Graft Delivery Device K100754 Device Description TniPore TDD is an open bore syringe prefilled with TniPore synthetic bone… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150064 | Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) | 2015 | 0 |
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 9 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K150064 (Orthogem, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070132.
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. 2011, 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?
TniPore TODHA, TDD 8 p90, and TDD5 PI5 is intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques *should be used in conjunction with this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110787 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110787: Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110787
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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