# K013790: Calcigen-S Bone Void Filer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jun 11, 2002 after 209 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 K960978 (1996). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960978: Wright Plaster of Paris Pellets (Subject to Revision), Wrightmedicaltechnologyinc (1996) Summary page 1.
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K963587: Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision), Wrightmedicaltechnologyinc (1997) Summary page 1.

## Most influential descendants
- K031319: Osteo-G Bone Void Filler System (2003), 4 descendants of its own
- K091688: A-Grix Resorbable Bone Void Filler (2010), 1 descendant of its own
- K121453: A-Grix TE Resorable Bone Void Filler (2013), 0 descendants of its own
- K072444: Wellgraft PE I (2008), 0 descendants of its own
- K072170: Wellgraft PE II (2008), 0 descendants of its own

## Indications for use
CalcigenTM-SBone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic injury to the bone. CalcigenTM-S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K013790
Methodology: https://510kreport.com/methodology