# K053445: Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 6, 2006 after 25 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: 5 generations back to P810020 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023012: Smartset HV Bone Cement, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K033563: Smartset GHV Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K042591: Smartmix Pre-Filled Mixing System, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K021499: Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement, DePuy Orthopaedics, Inc. (2002) Summary page 1.

## Indications for use
SmartSet HV Bone Cement is indicated for the Fixation of prostheses to living bone in orthopaedic musctloskeletal 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. SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stagzc of a tvo-stage revision for total joint arthroplasty after the initial infection has been cleared

Source page: https://510kreport.com/device/K053445
Methodology: https://510kreport.com/methodology