510(k) · Cleared
ClearedCytrans™ Elashield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Jul 6, 2026 as substantially equivalent to K090083 (Unicare Biomedical, Inc., 2009) and 1 other predicate after a 279-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jul 6, 2026
- Review
- 279 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K924408 (1995). 37 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 6 generations between
- 3 generations backK140518 Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014
- 2 generations backK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- 1 generation backK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
- This deviceK253317 Cytrans™ ElashieldGC America, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 9 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 8 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 7 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 6 generations backK061244 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006
- 5 generations backK073711 Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008
- 4 generations backK102531 MucograftEd. Geistlich Soehne AG Fur Chemische Industrie · 2010
- 3 generations backK140518 Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014
- 2 generations backK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- 1 generation backK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
- This deviceK253317 Cytrans™ ElashieldGC America, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −9 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −8 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −7 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −6 | K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006 | — |
| −5 | K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008 | — |
| −4 | K102531 | Mucograft | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010 | — |
| −3 | K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM Diameter | Geistlich Pharma AG | 2014 | — |
| −2 | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2019 | — |
| −1 | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2022 | — |
| 0 (this device) | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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 K253883 Bonalive Maxillofacialscore 12.8 · 6 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 |
|---|---|---|---|
| * | K090083 | Cytoflex Resorb, Model C03-0010 Through C03-090Summary page 5…Product Applicant 510(k) No. Code No Predicate Decision Date CytoFlex® Resorb UNICARE BIO- K090083 LYC Primary 03/23/2009 MEDICAL, INC. Geistlich Bio-Gide® Gei… | 2009 |
| * | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Summary page 5…BIO- K090083 LYC Primary 03/23/2009 MEDICAL, INC. Geistlich Bio-Gide® Geistlich Pharma K212463 NPL Secondary 04/05/2022 AG 4. Description of Device: Cytrans™ Ela… | 2022 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 37 ancestors have a recall of any class.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Cytrans™ Elashield is intended for the following uses as a space-making barrier:
Guided bone regeneration in oral surgery
Alveolar ridge augmentation
Guided tissue regeneration in periodontal defects
Extraction socket site preservation
Sinus lifts
Immediate implant placement at time of extraction or delayed placement
Treatment of associated cystic defect
The containment of bone grafting materials
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/K253317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253317: Cytrans™ Elashield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253317
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026