Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416)
Description
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® by Stryker, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230416
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; Triathlon® Revision Insert X3® (K230416) cites 7 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stry... | 2023 |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stry... | 2023 |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | Howmedica Osteonics Corp. A.K.A. St... | 2017 |
| 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 |
Trace the full predicate network for K230416
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.