510(k) · Cleared
ClearedCeros TCP Granules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mathys, Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Sep 15, 2010 as substantially equivalent to K053022 (Synthes (Usa), 2006) and 2 other predicates after a 117-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 15, 2010
- Review
- 117 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K941780 (1995). 25 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 3 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 2 generations backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- 1 generation backK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- This deviceK101426 Ceros TCP GranulesMathys, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −3 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −2 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| −1 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| 0 (this device) | K101426 | Ceros TCP Granules | Mathys, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K053022 | Synthes (Usa) Chronos-Beta-TCPSummary page 2…edicate devices, each of which has been determnined by FDA to be substantially equivalent to pre-amendment devices: Synthes (USA) chronOSTM - P-TCP cleared under K053022, Curasan AG Cerasorb® DENTAL and Cerasorb® M DENTAL cleared under K05 1443 BioForm, Inc., Calcium Hydroxylapatite… | 2006 |
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 2…ivalent to pre-amendment devices: Synthes (USA) chronOSTM - P-TCP cleared under K053022, Curasan AG Cerasorb® DENTAL and Cerasorb® M DENTAL cleared under K05 1443 BioForm, Inc., Calcium Hydroxylapatite Implant cleared under K030682. The subject device and the predicate devices have… | 2005 |
| * | K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Summary page 2…red under K053022, Curasan AG Cerasorb® DENTAL and Cerasorb® M DENTAL cleared under K05 1443 BioForm, Inc., Calcium Hydroxylapatite Implant cleared under K030682. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2003 |
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 15 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 25 ancestors has a recall.
- 2 other devices also cite its predicate K053022.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros® TCP Granules may, for example, be used for: * supplementing autogenous cancellous bone * supporting and stabilizing for guided bone regeneration, "GBR" * filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection…
Read the full statement (176 words)
Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros® TCP Granules may, for example, be used for:
* supplementing autogenous cancellous bone
* supporting and stabilizing for guided bone regeneration, "GBR"
* filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy
* filling bone defects resulting from traumatic or pathological origin
* augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)
* filling defects after explantation of dental implants
* filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
* the reconstruction of alveolar defects prior to providing a prosthesis
* preparation of the implant bed (e.g. sinus lift)
* filling bone defects around dental implant after immediate placement into extraction sockets
Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101426: Ceros TCP Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101426
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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