# K031430: Cemex System Fast

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: May 22, 2003 after 16 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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 K000943 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000943: Cemex System Gun Application Version, Exactech, Inc. (2001) Summary page 2.

## Indications for use
CEMEX bone cement is indicated for the fixation of protheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular. necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.

Source page: https://510kreport.com/device/K031430
Methodology: https://510kreport.com/methodology