# K152077: MaxiGen

- Pathway: 510(k) (Traditional)
- Applicant: Hans Biomed Corp.
- Decided: Apr 21, 2016 after 269 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 K040980 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 4.
- K053319: Allomatrix Custom, Wrightmedicaltechnologyinc (2006) Summary page 4.
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty, Hans Biomed Corp. (2012) Summary page 4.

## Indications for use
MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process

Source page: https://510kreport.com/device/K152077
Methodology: https://510kreport.com/methodology