# K972278: Cytoplast Regentex Titanium 250

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Co.
- Decided: Aug 6, 1997 after 49 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922627 (1994). 5 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960292: Gore-Tex Regenerative Material Titanium Reinforced Configurations, W. L. Gore & Associates, Inc. (1996) Summary page 1.
- K964342: Cytoplast GBR, Osteogenics Co. (1997) Summary page 1.

## Most influential descendants
- K143327: Neoss Ti Reinforced Membrane (2015), 2 descendants of its own
- K201187: Cytoplast Titanium-Reinforced PTFE Membranes (2021), 1 descendant of its own
- K091120: Medpor Contain Implant (2010), 1 descendant of its own
- K221851: Lumina-PTFE Titanium (2023), 0 descendants of its own
- K210797: Bio-MEM Ti Reinforced Membrane (2022), 0 descendants of its own

## Recalls of this device
- Sep 7, 2016 · Class II · Z-0113-2017: The device has the potential to be packaged in the wrong product box.

## Indications for use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.

Source page: https://510kreport.com/device/K972278
Methodology: https://510kreport.com/methodology