# K121453: A-Grix TE Resorable Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Ag Digital Technology Corp.
- Decided: Feb 5, 2013 after 265 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 K963587 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091688: A-Grix Resorbable Bone Void Filler, Ag Digital Technology Corp. (2010) Summary page 2.

## Indications for use
A-GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is repl~ced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.

Source page: https://510kreport.com/device/K121453
Methodology: https://510kreport.com/methodology