# K041493: Cementek

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed, S.A.
- Decided: Aug 19, 2004 after 76 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 K011048 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022622: Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30P, Berkeley Advanced Biomaterials, Inc. (2003) Summary page 1.
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Indications for use
Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K041493
Methodology: https://510kreport.com/methodology