# K051698: Merries Uni-Osteo, Model CS30250-CS10102

- Pathway: 510(k) (Traditional)
- Applicant: Merries International, Inc.
- Decided: Sep 29, 2005 after 97 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963587 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963587: Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision), Wrightmedicaltechnologyinc (1997) Summary page 2.
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 2.
- K010555: JAX, Smith & Nephew, Inc. (2003) Summary page 2.

## Indications for use
Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K051698
Methodology: https://510kreport.com/methodology