# K033509: Modification to Versabond Bone Cement

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 28, 2003 after 22 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 K001160 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001160: Versabond Bone Cement, Smith & Nephew, Inc. (2000) Summary page 1.

## Most influential descendants
- K022688: Versabond AB Bone Cement (2004), 0 descendants of its own

## Indications for use
VersaBond" Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

Source page: https://510kreport.com/device/K033509
Methodology: https://510kreport.com/methodology