# K023012: Smartset HV Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 13, 2003 after 156 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 P810020 (1984). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 15 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.
- P810020: Palacos R Bone Cement, Smith & Nephew Richards, Inc. (1984) Summary page 1.

## Most influential descendants
- K033563: Smartset GHV Gentamicin Bone Cement (2004), 9 descendants of its own
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement (2004), 8 descendants of its own
- K053002: Depuy CMW 1 Gentamicin Bone Cement (2005), 4 descendants of its own
- K173494: OrthoSteady G Bone Cement (2018), 2 descendants of its own
- K081155: Smartset MV Bone Cement (2008), 1 descendant of its own

## Indications for use
SmartSet HV 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/K023012
Methodology: https://510kreport.com/methodology