# K234028: COPAL® exchange G hip spacer; COPAL® G+V

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: Feb 15, 2024 after 57 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: 6 generations back to K000943 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, Osteoremedies, LLC (2018) Summary page 5.

## Indications for use
COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period. COPAL® G+V (gentamicin and vancomycin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.

Source page: https://510kreport.com/device/K234028
Methodology: https://510kreport.com/methodology