# K033611: Calcigen -Nap Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 27, 2004 after 162 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: 2 generations back to K960978 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011386: Ebi Osteostim Granules-Resorbable Bone Graft Substitute, Ebi, L.P. (2001) Summary page 1.
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 1.
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001) Summary page 1.
- K003493: 3I Calcium Sodium Phosphate Bone Cement, Biomet, Inc. (2001) Summary page 1.

## Indications for use
Calcigen T '-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Source page: https://510kreport.com/device/K033611
Methodology: https://510kreport.com/methodology