# K023103: Depuy 1 Gentamicin Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 29, 2003 after 376 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
No predicates in its family tree.
19 later devices descend from it; 4 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)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy 1 Bone Cement: named in the summary without a submission number
- (no number) BACTISEAL Catheter (Codman): named in the summary without a submission number
- (no number) OrthoGuard AB Antimicrobial Sleeve (Smith and Nephew): named in the summary without a submission number

## Most influential descendants
- K033382: Smartset GMV Endurance Gentamicin Bone Cement (2004), 16 descendants of its own
- 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

## Indications for use
DePuy 1 Gentamicin 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/K023103
Methodology: https://510kreport.com/methodology