# K051380: Triathlon Press-Fit Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 30, 2005 after 95 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031729 (2003). 5 ancestors in all.
54 later devices descend from it; 8 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component, Howmedica Osteonics Corp. (2005) Summary page 2.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 2.
- K032163: Duracon Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 2.
- K032418: Duracon Total Knee System with Peri-Apatite Coating, Howmedica Osteonics Corp. (2003) Summary page 2.

## Most influential descendants
- K123486: Triathlon Tritanium Tibial Baseplate (2013), 51 descendants of its own
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 descendants of its own
- K072575: Triathlon Screw-Fixation Tibial Baseplate (2008), 29 descendants of its own
- 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

## Recalls of this device
- Sep 21, 2006 · Not classified · Z-0579-2009: Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.

## Indications for use
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 proximal 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/K051380
Methodology: https://510kreport.com/methodology