# K081155: Smartset MV Bone Cement

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 14, 2008 after 21 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 P810020 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- P960001: Depuy 1 Bone Cement, Depuy, Inc. (1997) Summary page 1.
- K023012: Smartset HV Bone Cement, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K260536: Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (2026), 0 descendants of its own

## Indications for use
SmartSet MV 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/K081155
Methodology: https://510kreport.com/methodology