510(k) · Cleared
ClearedStraumann BoneCeramic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · LYC Bone Grafting Material, Synthetic
Cleared on Sep 24, 2020 as substantially equivalent to K040646 (The Straumann Co., 2004) after a 156-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Sep 24, 2020
- Review
- 156 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960978 (1996). 12 ancestors in all, the oldest K960164 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 1 generation backK040646 Straumann GranulesThe Straumann Co. · 2004
- This deviceK201051 Straumann BoneCeramicInstitut Straumann AG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −1 | K040646 | Straumann Granules | The Straumann Co. | 2004 | — |
| 0 (this device) | K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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? (1)
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 |
|---|---|---|---|
| * | K040646 | Straumann GranulesSummary page 5…Straumann® BoneCeramic 510(k) Summary 5.3 Predicate Device(s) Primary Predicate: K040646 - Straumann Granules 5.4 Device Description Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical g… | 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 24 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K040646.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:
Intrabony periodontal osseous and furcation defects
Augmentation of bony defects of the alveolar ridge
Filling tooth extraction sites
Sinus elevation grafting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201051 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201051: Straumann BoneCeramic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201051
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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