510(k) · Cleared
Recalled · Class II · 2016Cytoplast Regentex Titanium 250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteogenics Co. · LYC Bone Grafting Material, Synthetic
Cleared on Aug 6, 1997 as substantially equivalent to K960292 (W. L. Gore & Associates, Inc., 1996) and 1 other predicate after a 49-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it. It has been recalled once.
- Decided
- Aug 6, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- LYC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922627 (1994). 5 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- 1 generation backK964342 Cytoplast GBROsteogenics Co. · 1997
- This deviceK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997
- Descendant · cites it directly · 2 of its ownK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK201187 Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK221851 Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais · 2023
- Descendant · 2 generations on · 0 of its ownK210797 Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K143327Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015 · cites it directly2descendants
- K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021 · cites it directly1descendant
- K091120Medpor Contain ImplantPorex Surgical, Inc. · 2010 · cites it directly1descendant
- K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais · 2023 · 2 generations on0descendants
- K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| −1 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| 0 (this device) | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | — |
| +1 | K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015 | — |
| +1 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021 | — |
| +1 | K091120 | Medpor Contain Implant | Porex Surgical, Inc. | 2010 | — |
| +2 | K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | 2023 | — |
| +2 | K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K960292 | Gore-Tex Regenerative Material Titanium Reinforced ConfigurationsSummary page 1…Non-Absorbable Barrier Membrane Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation. lil. PREDICATE DEVICES Gore-Tex™ Regenerative Material (K960292; W.L Gore & Associates, Inc.) Cytoplast'™ GBR Membrane (K964342; Osteogenics Co.) IV. DEVICE DESCRIPTION The Cytoplast™ Regente… | 1996 |
| * | K964342 | Cytoplast GBRSummary page 1…ndosseous For Bone Filling And/Or Augmentation. lil. PREDICATE DEVICES Gore-Tex™ Regenerative Material (K960292; W.L Gore & Associates, Inc.) Cytoplast'™ GBR Membrane (K964342; Osteogenics Co.) IV. DEVICE DESCRIPTION The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of na… | 1997 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2016 | Class II | Z-0113-2017 | Labeling mix-ups | The device has the potential to be packaged in the wrong product box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K143327 (Neoss, Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K960292.
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?
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone 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/K972278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972278: Cytoplast Regentex Titanium 250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972278
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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