Class Class II
Triathlon® Hinge Knee System (K223528)
Description
Triathlon® Hinge Knee System by Howmedica Osteonics Corp., Dba Stryker Orthopaedics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223528
Clearance Date2023-01-20
Clearance TypeTraditional
Product CodeKRO
Regulation Number888.3510
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223528
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. Triathlon® Hinge Knee System (K223528) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris... | Stryker Orthopaedics | 2017 |
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | Stryker Orthopaedics | 2014 |
| K072221 | MODIFICATION TO TRIATHLON TS KNEE SYSTEM | Howmedica Osteonics Corp. | 2007 |
| K070095 | TRIATHLON TS KNEE SYSTEM | Howmedica Osteonics Corp. | 2007 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stry... | 2025 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | 2023 |
Trace the full predicate network for K223528
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.