# K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 12, 2005 after 72 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031729 (2003). 1 ancestor in all.
90 later devices descend from it; 7 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 1.

## Most influential descendants
- K070095: Triathlon TS Knee System (2007), 64 descendants of its own
- K051380: Triathlon Press-Fit Total Knee System (2005), 54 descendants of its own
- K123486: Triathlon Tritanium Tibial Baseplate (2013), 51 descendants of its own
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 descendants of its own
- K072221: Modification to Triathlon TS Knee System (2007), 35 descendants of its own

## Recalls of this device
- Aug 15, 2014 · Class II · Z-1635-2015: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

## Indications for use
The Triathlon™ PS Femoral Component is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. 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/K042993
Methodology: https://510kreport.com/methodology