# K042591: Smartmix Pre-Filled Mixing System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 22, 2004 after 29 days
- Product code: KIH (Dispenser, Cement)
- Device class: 1
- Regulation: 21 CFR 888.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P810020 (1984). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 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.
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K021499: Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement, DePuy Orthopaedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K053445: Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement (2006), 0 descendants of its own

## Indications for use
SmartSet MV Endurance Bone Cement is 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. SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K042591
Methodology: https://510kreport.com/methodology