510(k) · Cleared
ClearedBioresorb Macro Pore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oraltronics Dental Implant Technology GmbH · LYC Bone Grafting Material, Synthetic
Cleared on Jul 15, 2005 as substantially equivalent to K014156 (Curasan AG, 2002) after a 162-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Jul 15, 2005
- Review
- 162 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K014156 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK014156 Cerasorb OrthoCurasan AG · 2002
- This deviceK050260 Bioresorb Macro PoreOraltronics Dental Implant Technology GmbH · 2005
- Descendant · cites it directly · 1 of its ownK083372 Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009
- Descendant · cites it directly · 1 of its ownK081561 Osferion DOlympus Terumo Biomaterials Corporation · 2008
- Descendant · 2 generations on · 0 of its ownK110198 Blue Sky Bio TCPBlue Sky Bio, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK091618 VitomatrixOrthovita, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K083372Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009 · cites it directly1descendant
- K081561Osferion DOlympus Terumo Biomaterials Corporation · 2008 · cites it directly1descendant
- K110198Blue Sky Bio TCPBlue Sky Bio, LLC · 2011 · 2 generations on0descendants
- K091618VitomatrixOrthovita, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014156 | Cerasorb Ortho | Curasan AG | 2002 | — |
| 0 (this device) | K050260 | Bioresorb Macro Pore | Oraltronics Dental Implant Technology GmbH | 2005 | — |
| +1 | K083372 | Arrowbone-a, Arrowbone-B | Brainbase Corporation | 2009 | — |
| +1 | K081561 | Osferion D | Olympus Terumo Biomaterials Corporation | 2008 | — |
| +2 | K110198 | Blue Sky Bio TCP | Blue Sky Bio, LLC | 2011 | — |
| +2 | K091618 | Vitomatrix | Orthovita, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K014156 | Cerasorb Ortho | 2002 |
What descends from it? (4)
2 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?
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?
BioResorb® is to be used as a bone void filler device used in guided tissue
regeneration, sinus lifts, ridge maintenance, alveolar socket preservation or ridge
augmentation, and the treatment of osseous defects.
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/K050260 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050260: Bioresorb Macro Pore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050260
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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