510(k) · Cleared
ClearedBio-Blocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geistlich-Pharma · LYC Bone Grafting Material, Synthetic
Cleared on Aug 14, 2000 after a 1,294-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 125 later devices descend from it.
- Decided
- Aug 14, 2000
- Review
- 1,294 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
125 later devices descend from it, 2 citing it directly.
- This deviceK970569 Bio-BlocksGeistlich-Pharma · 2000
- Descendant · cites it directly · 124 of its ownK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- Descendant · cites it directly · 55 of its ownK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 40 of its ownK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
- Descendant · 3 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- Descendant · 4 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004 · cites it directly124descendants
- K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · cites it directly55descendants
- K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006 · 2 generations on40descendants
- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 3 generations on38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970569 | Bio-Blocks | Geistlich-Pharma | 2000 | — |
| +1 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| +1 | K043034 | Osteoguide Anorganic Bone Mineral Products | Collagen Matrix, Inc. | 2005 | 3 |
| +2 | K052812 | Ossimend (TM) Bone Graft Material | Collagen Matrix, Inc. | 2006 | — |
| +3 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +4 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 10 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (125)
See all 1252 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?
- Of its descendants, K033815 (Geistlich-Pharma, 2004) has gone furthest, with 124 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?
Augmentation of reconstructive treatment of the alveolar ridge
Filling of defects after root resection, apicoectomy and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970569: Bio-Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970569
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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