# K222570: COPAL knee moulds

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: Feb 4, 2023 after 165 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K936159 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032522: Tecres Spacer-K Temporary Knee Prosthesis, Exactech, Inc. (2004) Summary page 4.

## Most influential descendants
- K243024: Cellbrick Knee Spacer (2024), 0 descendants of its own

## Indications for use
COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer molds indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Source page: https://510kreport.com/device/K222570
Methodology: https://510kreport.com/methodology