# K050490: Osmosys Calcium Phosphate Ceramic Bone Filler

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea
- Decided: Apr 11, 2005 after 45 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: 4 generations back to K960978 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030178: Calcigen Psi Bone Graft Substitute, Biomet, Inc. (2003) Summary page 1.
- K020986: Mastergraft Resorbable Ceramic, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## Indications for use
OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K050490
Methodology: https://510kreport.com/methodology