# K053003: Depuy CMW 1, 2 and 3 Bone Cements

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 22, 2005 after 27 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: 2 generations back to P960001 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960001: Depuy 1 Bone Cement, Depuy, Inc. (1997) Summary page 1.
- K033382: Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K212729: Bone Cement-Normal Viscosity (2022), 0 descendants of its own
- K061144: Depuy CMW 2  and CMW 3 Gentamicin Bone Cement (2006), 0 descendants of its own

## Indications for use
DePuy CMW 1, 2 and 3 Bone Cements are indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Source page: https://510kreport.com/device/K053003
Methodology: https://510kreport.com/methodology