Class Class II
Klassic Knee Revision System (K230537)
Description
Klassic Knee Revision System by Total Joint Othopedics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230537
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230537
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. Klassic Knee Revision System (K230537) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic K... | Total Joint Orthopedics, Inc. | 2019 |
| K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | Total Joint Orthopedics, Inc. | 2014 |
| K112906 | KLASSIC KNEE SYSTEM | Total Joint Orthopedics, Inc. | 2012 |
| K070095 | TRIATHLON TS KNEE SYSTEM | Howmedica Osteonics Corp. | 2007 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025 |
Trace the full predicate network for K230537
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.