# K200452: Meril-Bonewax

- Pathway: 510(k) (Traditional)
- Applicant: M/s. Meril Endo Surgery Private Limited.
- Decided: Mar 27, 2023 after 1,127 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: 3 generations back to K791495 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024372: CP Medical Bone Wax, Cp Medical (2003) Summary page 4.
- K050292: Sharpoint Lukens Bone Wax, Surgical Specialties Corp (2005) Summary page 4.

## Indications for use
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.

Source page: https://510kreport.com/device/K200452
Methodology: https://510kreport.com/methodology