Class Class II
COPAL knee moulds (K222570)
Description
COPAL knee moulds by Heraeus Medical GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222570
Clearance Date2023-02-04
Clearance TypeTraditional
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222570
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. COPAL knee moulds (K222570) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K032522 | TECRES SPACER-K TEMPORARY KNEE PROSTHESIS | Exactech, Inc. | 2004 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | 2024 |
Trace the full predicate network for K222570
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.