# K040514: Eovia Calcium Phosphate Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Tec, LLC
- Decided: May 3, 2004 after 66 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 (2009), 2 descendants of its own
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own
- K071121: Tribone 80 (2007), 0 descendants of its own
- K063527: MBCP+ (2007), 0 descendants of its own

## Indications for use
EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EOVIA Calcium Phosphate Ceramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K040514
Methodology: https://510kreport.com/methodology