# K021715: Cemex RX, Cemex Isoplastic & Cemex XL

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jun 12, 2002 after 20 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 1.
- (no number) CMW3: named in the summary without a submission number
- (no number) Simplex P: named in the summary without a submission number
- (no number) Palacos R: named in the summary without a submission number
- (no number) Dough-Type: named in the summary without a submission number

## Most influential descendants
- K143134: NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System (2015), 2 descendants of its own
- K211163: Bone Cement Genta, Bone Cement HV, Bone Cement LV (2023), 0 descendants of its own
- K210120: BonOs HV, BonOs MV, BonOs LV (2021), 0 descendants of its own

## 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/K021715
Methodology: https://510kreport.com/methodology