# K153095: ROP Resorbable Hemostasis Material

- Pathway: 510(k) (Traditional)
- Applicant: Resorbable Orthopedic Products, LLC
- Decided: Feb 17, 2016 after 114 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K791495 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082491: Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene, Ceremed, Inc. (2008) Summary page 4.

## Indications for use
ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.

Source page: https://510kreport.com/device/K153095
Methodology: https://510kreport.com/methodology