510(k) · Cleared
ClearedTribone 80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomatlante · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 11, 2007 as substantially equivalent to K040514 (Ortho Tec, LLC, 2004) and 1 other predicate after a 144-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 11, 2007
- Review
- 144 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963587 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- 2 generations backK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
- 1 generation backK033258 Bonesave Bone Void FillerHowmedica Osteonics · 2004
- This deviceK071121 Tribone 80Biomatlante · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| −2 | K991854 | Osteoplast, Model POP200 | Interpore Cross Intl. | 1999 | — |
| −1 | K033258 | Bonesave Bone Void Filler | Howmedica Osteonics | 2004 | — |
| 0 (this device) | K071121 | Tribone 80 | Biomatlante | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K040514 | Eovia Calcium Phosphate CeramicSummary page 1…2. PREDICATE DEVICES FProdumc-tCodeI Aplicant ___ 510{4 _k_ ___ Product __ MQVVOrthotec 4 K040514 EOVIA MQV Ort h o ::ec M-QV _ Howmedica [ K033258… | 2004 |
| * | K033258 | Bonesave Bone Void FillerSummary page 1…hotec 4 K040514 EOVIA MQV Ort h o ::ec M-QV _ Howmedica [ K033258 Bone Save 3. DEVICE DESCRIPTION TRIBONE 8OTM is a bone graft substitute. TRIBONE 8OTM is a microp… | 2004 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K040514.
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. 2007, 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?
TRIBONE 8OTM is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. TRIBONE 8OTM is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When…
Read the full statement (115 words)
TRIBONE 8OTM is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
TRIBONE 8OTM is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, TRIBONE 8OTM gradually resorbs and is replaced with bone during the healing process.
TRIBONE 8 0 TM is to be used in association with adequate post-operative immobilization.
TRIBONE 80 TM is provided sterile for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071121 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071121: Tribone 80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071121
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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