# K210797: Bio-MEM Ti Reinforced Membrane

- Pathway: 510(k) (Traditional)
- Applicant: B&Medi Co., Ltd.
- Decided: Aug 18, 2022 after 520 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: 4 generations back to K922627 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143327: Neoss Ti Reinforced Membrane, Neoss, Ltd. (2015) Summary page 4.

## Indications for use
Bio-MEM Ti Reinforced membranes are 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. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.

Source page: https://510kreport.com/device/K210797
Methodology: https://510kreport.com/methodology