510(k) · Cleared
ClearedOsferion D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Terumo Biomaterials Corporation · LYC Bone Grafting Material, Synthetic
Cleared on Jul 28, 2008 as substantially equivalent to K051443 (Curasan Ag, Frankfurt Facility, 2005) and 1 other predicate after a 55-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Jul 28, 2008
- Review
- 55 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941780 (1995). 20 ancestors in all, the oldest P800035 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 3 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 2 generations backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- 1 generation backK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- This deviceK081561 Osferion DOlympus Terumo Biomaterials Corporation · 2008
- Descendant · cites it directly · 0 of its ownK091618 VitomatrixOrthovita, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K091618VitomatrixOrthovita, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −3 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −2 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| −1 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| 0 (this device) | K081561 | Osferion D | Olympus Terumo Biomaterials Corporation | 2008 | — |
| +1 | K091618 | Vitomatrix | Orthovita, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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 |
|---|---|---|---|
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 2…TERUMO Technology BIOMATERIALS GmbH CORP. 510(k) No. K051443 K050260 K080065 K032409 4 Device Description OSferion D is a white porous mat… | 2005 |
| * | K050260 | Bioresorb Macro PoreSummary page 2…Technology BIOMATERIALS GmbH CORP. 510(k) No. K051443 K050260 K080065 K032409 4 Device Description OSferion D is a white porous material composed of Bet… | 2005 |
| † | K080065 | Osferion | 2008 |
| † | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | 2003 |
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 |
|---|---|---|---|
| K091618 | Vitomatrix | 2010 | 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 13 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K091618 (Orthovita, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K051443.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectomy, and cystectomy.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081561: Osferion D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081561
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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