510(k) · Cleared
ClearedMastergraft Resorbable Ceramic Granules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · LYC Bone Grafting Material, Synthetic
Cleared on Jan 9, 2009 as substantially equivalent to K020986 (Medtronic Sofamor Danek, Inc., 2002) and 1 other predicate after a 101-day review. Its family tree reaches back 5 generations to 1999. 3 later devices descend from it.
- Decided
- Jan 9, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K990131 (1999). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK032268 MBCPBiomatlante · 2003
- 2 generations backK043005 Modification to MBCPBiomatlante · 2005
- 1 generation backK051885 MBCPBiomatlante · 2005
- This deviceK082917 Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek · 2009
- Descendant · cites it directly · 0 of its ownK100986 Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler…Skeletal Kinetics, LLC · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK093871 Periophil B-TCPCytophil, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK092087 Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC · 2010 · cites it directly0descendants
- K093871Periophil B-TCPCytophil, Inc. · 2010 · cites it directly0descendants
- K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −4 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K032268 | MBCP | Biomatlante | 2003 | — |
| −2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −1 | K051885 | MBCP | Biomatlante | 2005 | — |
| 0 (this device) | K082917 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek | 2009 | — |
| +1 | K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation | Skeletal Kinetics, LLC | 2010 | 11 |
| +1 | K093871 | Periophil B-TCP | Cytophil, Inc. | 2010 | — |
| +1 | K092087 | Medtronic Dental TCP | Medtronic Sofamor Danek USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K020986 | Mastergraft Resorbable CeramicSummary page 1…so that it may be used in the oral and maxillofacial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP TM (K051885, SE 09116/2005), the subject system is intended to be used alone o… | 2002 |
| * | K051885 | MBCPSummary page 1…nd maxillofacial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP TM (K051885, SE 09116/2005), the subject system is intended to be used alone or combined with autograft as a bone void filler… | 2005 |
What descends from it? (3)
3 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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K100986 (Skeletal Kinetics, LLC, 2010) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K020986.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the…
Read the full statement (149 words)
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Procedures specific to MASTERGRAFT® Granules include:
• Filling of dental extraction sockets
• Filling of cystic defects
• Oral/maxillofacial augmentation or reconstruction.
Procedures specific to MASTERGRAFT® Mini Granules include:
• Filling of periodontal defects
• Sinus lifts
• Alveolar ridge augmentation
• Filling of dental extraction sockets
• Filling of cystic defects
• Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082917: Mastergraft Resorbable Ceramic Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082917
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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