510(k) · Cleared
Recalled · 2006TRIHA +
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed, S.A. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 28, 2003 as substantially equivalent to K021963 (Sciences ET Bio Materiaux (Sbm), 2003) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 28, 2003
- Review
- 168 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K994337 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 1 generation backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- This deviceK031826 TRIHA +Teknimed, S.A. · 2003
- Descendant · cites it directly · 1 of its ownK040669 Ceraform Bone Void FillerTeknimed, S.A. · 2004
- Descendant · 2 generations on · 0 of its ownK042911 Cementek LVTeknimed, S.A. · 2004
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 |
|---|---|---|---|---|---|
| −2 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −1 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| 0 (this device) | K031826 | TRIHA + | Teknimed, S.A. | 2003 | — |
| +1 | K040669 | Ceraform Bone Void Filler | Teknimed, S.A. | 2004 | — |
| +2 | K042911 | Cementek LV | Teknimed, S.A. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K021963 | Biosorb Resorbable Void Filler Our reading of the summary gave K021763, FDA’s number for RS2MI Muscle Stimulator Family (Rs Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BIOSORB”. | 2003 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…888.3045) Equivalent Device TRIHA+ is equivalent in material, indications and use as BIOSORB (K021763) (Sciences et Bio Materiaux, Lourdes, France) and VitossTMScaffold (K994337) (Orthovita, Inc. (Malvern PA). Device Description THIHA+ is an osseo-conductive macroporous implant made of synthetic beta t r… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040669 | Ceraform Bone Void Filler | 2004 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2006 | Not classified | Z-0423-2007 | Other | The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K040669 (Teknimed, S.A., 2004) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K021963.
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?
TRIHA+ is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. TRIHA+ is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. TRIHA+ should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
TRIHA+ is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031826: TRIHA +.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031826
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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