510(k) · Cleared
ClearedBlue Sky Bio TCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Sky Bio, LLC · LYC Bone Grafting Material, Synthetic
Cleared on Dec 22, 2011 as substantially equivalent to K051443 (Curasan Ag, Frankfurt Facility, 2005) and 1 other predicate after a 332-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 22, 2011
- Review
- 332 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941780 (1995). 21 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 4 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 3 generations backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- 2 generations backK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- 1 generation backK083372 Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009
- This deviceK110198 Blue Sky Bio TCPBlue Sky Bio, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −4 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −3 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| −2 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| −1 | K083372 | Arrowbone-a, Arrowbone-B | Brainbase Corporation | 2009 | — |
| 0 (this device) | K110198 | Blue Sky Bio TCP | Blue Sky Bio, LLC | 2011 | — |
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 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | 2005 |
| * | K083372 | Arrowbone-a, Arrowbone-BSummary page 6…g of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) K083372 ArrowBone-P ArrowBone-P is intended for use in the 8 December BrainBase… | 2009 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 21 ancestors has a recall.
- 16 other devices also cite its predicate K051443.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
Filling of periodontal/infrabony defects
Ridge augmentation
Filling of extraction sites (implant preparation/placement)
Sinus lifts
Filling of cystic cavities
The device gradually resorbs and is replaced with bone during the healing process.
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/K110198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110198: Blue Sky Bio TCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110198
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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