510(k) · Cleared
ClearedOsferion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Terumo Biomaterials Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on May 2, 2008 as substantially equivalent to K043045 (Synthes (Usa), 2005) and 2 other predicates after a 113-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 2, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K013072 (2002). 5 ancestors in all, the oldest K994337 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013072 | Chronos Tricalcium Prosphate (Chronos TCP) | Synthes | 2002 | — |
| −1 | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita, Inc. | 2003 | — |
| 0 (this device) | K080065 | Osferion | Olympus Terumo Biomaterials Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K043045 | Synthes (Usa) ChronosSummary page 2…BIOMATERIALS CORP. 510(k) No. K043045 K032409 K061499 4 Device Description OSferion is a white porous material compo… | 2005 |
| * | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 2…BIOMATERIALS CORP. 510(k) No. K043045 K032409 K061499 4 Device Description OSferion is a white porous material composed of P-trcalcium phosphate(P-TC… | 2003 |
| * | K061499 | OsferionSummary page 2…RIALS CORP. 510(k) No. K043045 K032409 K061499 4 Device Description OSferion is a white porous material composed of P-trcalcium phosphate(P-TCP). It is intended to… | 2007 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K043045.
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. 2008, 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?
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure.
Following placement in the bony void 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/K080065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080065: Osferion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080065
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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