510(k) · Cleared
ClearedBio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Interfaces, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Apr 10, 1996 after an 85-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 10, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK960164 Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles -…Bio-Interfaces, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK040646 Straumann GranulesThe Straumann Co. · 2004
- Descendant · 2 generations on · 0 of its ownK201051 Straumann BoneCeramicInstitut Straumann AG · 2020
- Descendant · 2 generations on · 0 of its ownK050170 Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960164 | Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140 | Bio-Interfaces, Inc. | 1996 | — |
| +1 | K040646 | Straumann Granules | The Straumann Co. | 2004 | — |
| +2 | K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020 | — |
| +2 | K050170 | Fortoss Vital Bone Graft Substitute | Biocomposites, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | allogeneic freeze-dried bone Named without a submission number | |
| * | — | Bii-GRAFT™ 1860 Named without a submission number | |
| * | — | Osteograf-LD™ synthetic materials Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040646 | Straumann Granules | 2004 | 2 |
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?
- Of its descendants, K040646 (The Straumann Co., 2004) has gone furthest, with 2 descendants of its own.
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?
for filing and contouring osseous defects such as periodontal lesions
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960164: Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960164
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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