# K030178: Calcigen Psi Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 26, 2003 after 40 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: 3 generations back to K960978 (1996). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013072: Chronos Tricalcium Prosphate (Chronos TCP), Synthes (2002)
- K011531: Calcium Phosphate Granular Bone Void Filler, Biomet, Inc. (2002)
- K013960: Apatight HA-Bone Graft Substitute, Cerabio, LLC (2002)
- K013966: Apatight-TCP Bone Graft Substitute, Cerabio, LLC (2002)
- K014156: Cerasorb Ortho, Curasan AG (2002)
- K014053: Conduit TCP Granules, Depuyacromed (2002)
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001)
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.
- (no number) Mastergraft Resorbable Ceramic: named in the summary without a submission number

## Most influential descendants
- K032286: Calcigen Psi Bone Graft Substitute (2003), 1 descendant of its own
- K063346: Pro Osteon 500R (2007), 0 descendants of its own
- K050490: Osmosys Calcium Phosphate Ceramic Bone Filler (2005), 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 iiijury to the bone. CalcigenTMPSI resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K030178
Methodology: https://510kreport.com/methodology