510(k) · Cleared
ClearedMedtronic Dental TCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Dec 30, 2009 as substantially equivalent to K082917 (Medtronic Sofamor Danek, 2009) and 2 other predicates after a 174-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Dec 30, 2009
- Review
- 174 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K990131 (1999). 26 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK032268 MBCPBiomatlante · 2003
- 3 generations backK043005 Modification to MBCPBiomatlante · 2005
- 2 generations backK051885 MBCPBiomatlante · 2005
- 1 generation backK082917 Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek · 2009
- This deviceK092087 Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −5 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K032268 | MBCP | Biomatlante | 2003 | — |
| −3 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −2 | K051885 | MBCP | Biomatlante | 2005 | — |
| −1 | K082917 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K092087 | Medtronic Dental TCP | Medtronic Sofamor Danek USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K082917 | Mastergraft Resorbable Ceramic GranulesSummary page 1…, resorbable bone void filler in the oral and maxillofacial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K082917, SE 01109109), Synthes (USA) chronOS Tm- P-TCP (K053022, SE 01/23/06) and Cerasorb® Dental (K051443, SE 07/22… | 2009 |
| * | K053022 | Synthes (Usa) Chronos-Beta-TCPSummary page 1…ial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K082917, SE 01109109), Synthes (USA) chronOS Tm- P-TCP (K053022, SE 01/23/06) and Cerasorb® Dental (K051443, SE 07/22/05), the subject system is intended as a bone void fill… | 2006 |
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 1…MASTERGRAFT® Resorbable Ceramic Granules (K082917, SE 01109109), Synthes (USA) chronOS Tm- P-TCP (K053022, SE 01/23/06) and Cerasorb® Dental (K051443, SE 07/22/05), the subject system is intended as a bone void filler for bony voids or gaps that are not intrinsic to th… | 2005 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 26 ancestors has a recall.
- 2 other devices also cite its predicate K082917.
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?
Medtronic Dental TOP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. Medtronic Dental TCP is intended for the…
Read the full statement (190 words)
Medtronic Dental TOP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.
Medtronic Dental TCP is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects. Procedures include:
*Ridge augmentation
*Sinus augmentation
*Filling of cystic defects
*Filling of extraction sites
*Filling of lesions of periodontal origin
*Craniofacial augmentation
*Filling of defects of endodontic origin
*Mandibular reconstruction
*Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
*Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall
Medtronic Dental TOP may be used alone, or in combination with saline, blood, bone marrow aspirate or platelet rich plasma (PRP).
Medtronic Dental TOP may be mixed with autograft as a bone graft extender.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092087: Medtronic Dental TCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092087
Report an extraction error
Are you the manufacturer?
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