# K053514: Triathlon Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Jan 26, 2006 after 41 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 7 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070095: Triathlon TS Knee System (2007), 64 descendants of its own
- K072221: Modification to Triathlon TS Knee System (2007), 35 descendants of its own
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P (2013), 33 descendants of its own
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own

## Recalls of this device
- Jan 24, 2013 · Class II · Z-0964-2013: The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
- Nov 13, 2008 · Not classified · Z-0889-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
General Total Knee Arthroplasty (TKA) Indications · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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 uni-knee replacement or other procedure. Additional Indications for Universal Baseplates and Stem Components: · Ligamentous instability requiring implant bearing surface geometries with increased constraint. · Absent or non-functioning posterior cruciate ligament. Indications for Bone Augments: Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied by bone loss. The Triathlon® Total Knee System components are intended for cemented use only.

Source page: https://510kreport.com/device/K053514
Methodology: https://510kreport.com/methodology