# K033382: Smartset GMV Endurance Gentamicin Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 5, 2004 after 105 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.
16 later devices descend from it; 7 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023103: Depuy 1 Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K014199: Surgical Simplex P with Tobramycin, Howmedica Osteonics Corp. (2003) Summary page 1.
- P960001: Depuy 1 Bone Cement, Depuy, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K071927: Modification to Vertebroplastic Radiopaque Bone Cement (2007), 2 descendants of its own
- K053003: Depuy CMW 1, 2 and 3 Bone Cements (2005), 2 descendants of its own

## Indications for use
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/K033382
Methodology: https://510kreport.com/methodology