# K021499: Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 24, 2002 after 76 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 P960001 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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)
- K000943: Cemex System Gun Application Version, Exactech, Inc. (2001)
- K002652: Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii, Stryker Corp. (2001)

## Most influential descendants
- K042591: Smartmix Pre-Filled Mixing System (2004), 1 descendant of its own
- K053445: Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement (2006), 0 descendants of its own

## Indications for use
CEMVAC Ultra pre-packed with DePuy 1 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.

Source page: https://510kreport.com/device/K021499
Methodology: https://510kreport.com/methodology