# K171774: RPM Reinforced PTFE Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Oct 19, 2017 after 127 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: 2 generations back to K963394 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984230: Osteo-Mesh TM-300, Osteogenics Biomedical, Inc. (1999) Summary page 4.

## Indications for use
RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

Source page: https://510kreport.com/device/K171774
Methodology: https://510kreport.com/methodology