# K143327: Neoss Ti Reinforced Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Neoss, Ltd.
- Decided: Apr 13, 2015 after 144 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922627 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 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 4.
- K972278: Cytoplast Regentex Titanium 250, Osteogenics Co. (1997) Summary page 4.

## Most influential descendants
- K210797: Bio-MEM Ti Reinforced Membrane (2022), 0 descendants of its own
- K151344: Cytoflex Tefguard Ti-Enforced Membrane (2015), 0 descendants of its own

## Indications for use
An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss Ti Reinforced Membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.

Source page: https://510kreport.com/device/K143327
Methodology: https://510kreport.com/methodology