510(k) · Cleared
ClearedStraumann Granules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Straumann Co. · LYC Bone Grafting Material, Synthetic
Cleared on May 3, 2004 as substantially equivalent to K990131 (Interpore Cross Intl., 1999) and 5 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- May 3, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K960978 (1996). 11 ancestors in all, the oldest K960164 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- This deviceK040646 Straumann GranulesThe Straumann Co. · 2004
- Descendant · cites it directly · 0 of its ownK201051 Straumann BoneCeramicInstitut Straumann AG · 2020
- Descendant · cites it directly · 0 of its ownK050170 Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd. · 2005
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 |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| 0 (this device) | K040646 | Straumann Granules | The Straumann Co. | 2004 | — |
| +1 | K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020 | — |
| +1 | K050170 | Fortoss Vital Bone Graft Substitute | Biocomposites, Ltd. | 2005 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2020 | 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? (6)
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 |
|---|---|---|---|
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 1…__ __ __ _ __ __ __ _ _ _ _ _ __ ___ ___ ___ C le a red Interpore Cross Pro-Osteon® 50OR Resorbable K990131 3/2/1 999 International Bone Graft Filler Medtronic Biphasic Calcium P… | 1999 |
| * | K010701 | Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void FillerSummary page 1…K990131 3/2/1 999 International Bone Graft Filler Medtronic Biphasic Calcium Phosphate K010701 6/5/2001 LSofamor Danek -Bone Void Filler Geistlich- Bio-Oss® Anorganic B… | 2001 |
| * | K970321 | Bio-Oss Anorganic Bovine BoneSummary page 1…K010701 6/5/2001 LSofamor Danek -Bone Void Filler Geistlich- Bio-Oss® Anorganic Bovine K970321 -~9/15/1998 [Pharma Bone______ Bio-lnterfaces, 1ii-GRAFT T M (Bioresorbable K… | 1998 |
| * | K960164 | Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140Summary page 1…anic Bovine K970321 -~9/15/1998 [Pharma Bone______ Bio-lnterfaces, 1ii-GRAFT T M (Bioresorbable K960164 -- _4/10/1996 Inc. Caciumn Phosphate) I_--__-_ B… | 1996 |
| * | K032268 | MBCPSummary page 1…-- _4/10/1996 Inc. Caciumn Phosphate) I_--__-_ Biomatlante MBCP I___K032268 1/1/2003 [Llmso~s NV OsSatura BCP Bone Void Filler 1K030131… | 2003 |
| * | K030131 | Ossatura BCP Bone Void FillerSummary page 1…Biomatlante MBCP I___K032268 1/1/2003 [Llmso~s NV OsSatura BCP Bone Void Filler 1K030131 05/20/2003 4. Description of the Device and Intended Use Straumann… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K201051 (Institut Straumann AG, 2020) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K990131.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040646 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040646: Straumann Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040646
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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