# K180612: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Jun 7, 2018 after 91 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943462 (1994). 84 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071881: Triathlon PKR System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 5.
- K150307: RESTORIS Multicompartmental Knee System, Mako Surgical Corp. (2015) Summary page 5.

## Most influential descendants
- K203099: Triathlon PKR System (2020), 1 descendant of its own
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own
- K220930: Restoris Multi-Compartmental Knee System (2022), 0 descendants of its own

## Indications for use
Mako X3® Uni Onlay Tibial Inserts are components of the RESTORIS Multicompartmental Knee (MCK) System that is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: * Medial unicondylar * Lateral unicondylar * Patellofemoral * Medial bi-compartmental (medial unicondylar and patellofemoral) RESTORIS Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement. Triathlon® PKR X3® Tibial Inserts are components of the Triathlon® PKR System that is indicated for: * Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis * Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis * As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis * Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau. These components are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K180612
Methodology: https://510kreport.com/methodology