# K091382: Kryptonite Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Doctors Research Group, Inc.
- Decided: Nov 16, 2009 after 189 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K873689 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040152: Bone Cement for Cranioplasty, Cardinalhealth (2004) Summary page 1.
- K011399: Biomet Craniofacial Acrylic Cement, Biomet, Inc. (2003)

## Recalls of this device
- Apr 6, 2012 · Not classified · Z-1496-2012: Bone cement strength and stiffness fall below specification at body temperature

## Indications for use
Kryptonite Bone Cement TM is a resinous material for repairing cranial defects.

Source page: https://510kreport.com/device/K091382
Methodology: https://510kreport.com/methodology