# K243024: Cellbrick Knee Spacer

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Dec 20, 2024 after 84 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: 3 generations back to K936159 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222570: COPAL knee moulds, Heraeus Medical GmbH (2023) Summary page 5.

## Indications for use
This product 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. This product 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.). During the implantation period, patients have to use traditional mobility assist devices (e.g. crutches, walkers, canes) for daily activities. With pre-clinical validations of antibiotic elution, tibial spacer fatigue test, and knee spacer wear test, only Palacos MV+G bone cement may be used for preparing the spacers.

Source page: https://510kreport.com/device/K243024
Methodology: https://510kreport.com/methodology