# K051146: Triathlon Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 13, 2005 after 70 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 6 cite it directly.
0 of 56 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 its predicate without a number.
- (no number) Triathlon® Tibial Inserts and Patellar: named in the summary without a submission number

## Most influential descendants
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert (2007), 40 descendants of its own
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 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
- K071881: Triathlon PKR System (2007), 25 descendants of its own

## Recalls of this device
- Dec 18, 2008 · Not classified · Z-1013-2009: Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code
- Dec 4, 2006 · Not classified · Z-0399-2007: A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size
- Dec 4, 2006 · Not classified · Z-0400-2007: A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Siz

## Indications for use
The Triathlon® X3TM UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3TM UHMWPE Pateliar components are intended to be used with the cemented Triathlon® PS and CR femoral 'components and cemented Triathlon ® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3TM UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon® CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The all polyethylene Triathlon® X3TM UHMWPE Patellar components are intended for implantation with bone cement only. Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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 pmximal tibia that cannot be stabilized by standard fracture management techniques. Additional Indications for Posterior Stabilized Components: * Ligamentous instability requiring implant bearing surface geometries with increased constraint. * Absent or non-functioning posterior cruciate ligament.

Source page: https://510kreport.com/device/K051146
Methodology: https://510kreport.com/methodology