# K032286: Calcigen Psi Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Nov 20, 2003 after 119 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). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 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)
- K022629: WMT-TCP Bone Graft Substitute, Wrightmedicaltechnologyinc (2002)
- K014156: Cerasorb Ortho, Curasan AG (2002)
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003)

## Most influential descendants
- K063346: Pro Osteon 500R (2007), 0 descendants of its own

## Indications for use
CalcigenTMPSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. CalcigenTMPSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. CalcigenTMPSI resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K032286
Methodology: https://510kreport.com/methodology