Clearance Summary
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts received FDA 510(k) clearance under submission number K180612, sponsored by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-06-07.
- Submission: K180612
- Applicant / Sponsor: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3520
- Decision date: 2018-06-07
Classification & Regulation
This clearance is catalogued under FDA product code HSX and 21 CFR 888.3520, within the Orthopedic review panel as a Class II device.