# K072575: Triathlon Screw-Fixation Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Jan 7, 2008 after 116 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031729 (2003). 6 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051380: Triathlon Press-Fit Total Knee System, Howmedica Osteonics Corp. (2005)
- K032418: Duracon Total Knee System with Peri-Apatite Coating, Howmedica Osteonics Corp. (2003) Summary page 2.

## Most influential descendants
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own
- K230952: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (2023), 4 descendants of its own

## Indications for use
General Total Knee Arthroplasty (TKR) Indications: * Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. * Post-traumatic loss of knee joint configuration and function. * Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. * Revision of previous unsuccessful knee replacement or other procedure. * Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques. Additional Indications for Posterior Stabilized (PS) Components: * Ligamentous instability requiring implant bearing surface geometries with increased constraint. * Absent or non-functioning posterior cruciate ligament. The Triathlon® Screw-fixation Tibial Baseplates are intended for cementless use only.

Source page: https://510kreport.com/device/K072575
Methodology: https://510kreport.com/methodology
