# K260536: Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: May 15, 2026 after 87 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P810020 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081155: Smartset MV Bone Cement, DePuy Orthopaedics, Inc. (2008) Summary page 5.
- (no number) DePuy Prostalac Hip System: named in the summary without a submission number

## Indications for use
The PROSTALAC Hip System is indicated for use as a short-term total hip replacement (THR) in patients who need a two-stage procedure to treat a confirmed infection of their THR and where vancomycin combined with either tobramycin OR gentamicin are the most appropriate antibiotics for treatment of the infection based on the susceptibility pattern of the infecting microorganism(s). SmartSet V+G Dual Antibiotic Bone Cement is intended for use with the DePuy Prostalac Hip System. The SmartSet V+G Dual Antibiotic Bone Cement is indicated for the formation and fixation of the DePuy Prostalac Hip System to the host bone.

Source page: https://510kreport.com/device/K260536
Methodology: https://510kreport.com/methodology