Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K180612 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Triathlon® Knee System

  Class II

  FDA 510(k) K261898 Active Cleared 6 Aug 2026

• Omnifit® 20° Series I Insert Open recall

  Class II

  FDA 510(k) K261624 Active Cleared 10 Jul 2026

• Stryker Orthopaedics Hip Systems Labeling Update

  Class II

  FDA 510(k) K240418 Active Cleared 12 Apr 2024

• UHR Bipolar Implants, Restoration GAP II Implants

  Class II

  FDA 510(k) K222632 Active Cleared 21 Oct 2022

• Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Open recall

  Class II

  FDA 510(k) K172634 Active Cleared 16 Nov 2017

• Restoration Anatomic Shell

  Class II

  FDA 510(k) K210893 Active Cleared 22 Apr 2021

See all devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics →

• What are the Triathlon PKR X3 Tibial Inserts and Mako X3 Uni Onlay Tibial Inserts used for?

  These tibial inserts are designed for partial knee replacement procedures, specifically to replace damaged articular surfaces within the knee joint. They restore function and alignment in partial knee arthroplasty by acting as a durable, ultra-high-molecular-weight polyethylene (UHMWPE) component. The Mako X3 Uni Onlay Tibial Inserts are engineered for use with robotic-assisted systems like the RIO Robotic Arm Interactive Orthopedic System, ensuring precise surgical placement.

• How are these tibial inserts supplied and what is their sterility status?

  The Triathlon PKR X3 Tibial Inserts and Mako X3 Uni Onlay Tibial Inserts are supplied as single-use, sterile devices. This ensures they meet strict medical-grade sterility standards before use in orthopedic surgical settings, minimizing infection risks and maintaining integrity for one surgical procedure only.

• Are these inserts reusable or intended for single-use?

  These tibial inserts are explicitly designed for single-use only. Single-use devices are engineered to maintain sterility and performance for one surgical procedure, reducing the risk of cross-contamination and ensuring consistent quality. Reusing them would compromise sterility and potentially compromise patient safety.

• What sizes are available for these tibial inserts, and how do they accommodate patient anatomy?

  The Triathlon PKR X3 Tibial Inserts and Mako X3 Uni Onlay Tibial Inserts come in multiple sizes to accommodate varying patient anatomies. The specific sizing ensures a precise fit for each patient’s knee joint, optimizing alignment and function during partial knee arthroplasty. Exact sizing details should be referenced in the product documentation or consulted with a surgical specialist.

• How should these tibial inserts be stored and handled before surgical use?

  These inserts must be stored and handled according to sterile medical device protocols to preserve their integrity. They should be kept in their original packaging until immediately before use, protected from contamination, moisture, and physical damage. Proper storage ensures sterility and maintains the device’s performance for the intended surgical procedure.