# K053002: Depuy CMW 1 Gentamicin Bone Cement

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 22, 2005 after 27 days
- Product code: MBB (Bone Cement, Antibiotic)
- 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: 4 generations back to P810020 (1984). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K033382: Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- P960001/S1: SmartSet MV Endurance Bone Cement. Number could not be read

## Most influential descendants
- K173494: OrthoSteady G Bone Cement (2018), 2 descendants of its own
- K193061: G3 40 Radiopaque Bone Cement (2020), 0 descendants of its own
- K193059: G1 40 Radiopaque Bone Cement (2020), 0 descendants of its own
- K061144: Depuy CMW 2  and CMW 3 Gentamicin Bone Cement (2006), 0 descendants of its own

## Indications for use
DePuy CMW 1 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/K053002
Methodology: https://510kreport.com/methodology