510(k) · Cleared
ClearedImtec Biobarrier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imtec Corp. · LYC Bone Grafting Material, Synthetic
Cleared on Feb 6, 1996 after a 377-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 6, 1996
- Review
- 377 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK950306 Imtec BiobarrierImtec Corp. · 1996
- Descendant · cites it directly · 11 of its ownK964342 Cytoplast GBROsteogenics Co. · 1997
- Descendant · 2 generations on · 7 of its ownK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- Descendant · 3 generations on · 2 of its ownK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK012144 CytoflexUnicare Biomedical, Inc. · 2001
- Descendant · 3 generations on · 1 of its ownK201187 Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K964342Cytoplast GBROsteogenics Co. · 1997 · cites it directly11descendants
- K972278Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · 2 generations on7descendants
- K143327Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015 · 3 generations on2descendants
- K012144CytoflexUnicare Biomedical, Inc. · 2001 · 2 generations on2descendants
- K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950306 | Imtec Biobarrier | Imtec Corp. | 1996 | — |
| +1 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| +2 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| +3 | K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015 | — |
| +2 | K012144 | Cytoflex | Unicare Biomedical, Inc. | 2001 | — |
| +3 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964342 | Cytoplast GBR | 1997 | 11 |
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?
- Of its descendants, K964342 (Osteogenics Co., 1997) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K950306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950306: Imtec Biobarrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950306
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026