# K191016: COPAL exchange G Hip and Knee Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: Nov 1, 2019 after 198 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936159 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101356: Spacer-G and Spacer-K, Tecres S.P.A. (2011) Summary page 4.

## Most influential descendants
- K220492: COPAL exchange G hip spacer (2022), 0 descendants of its own

## Indications for use
COPAL® exchange G Knee Spacer: COPAL® exchange G knee (polymethylmethacrylate/gentamicin) is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. COPAL® exchange G knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G knee 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 knee is only indicated for patientswho will consistently use traditional mobility assist devices e.g. crutches, walkers, canes) throughout the implantation period. COPAL® exchange G Hip Spacer: COPAL® exchange G hip (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 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, perm etc.). COPAL® exchange G hip is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Source page: https://510kreport.com/device/K191016
Methodology: https://510kreport.com/methodology