# K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 2, 2003 after 90 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.
109 later devices descend from it; 15 cite it directly.
0 of 110 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) Duracon Monolithic Stabilizer Femoral Component: named in the summary without a submission number
- (no number) Duracon Cruciform Tibial Baseplate: named in the summary without a submission number
- (no number) Duracon PS Lipped Tibial Insert: named in the summary without a submission number
- (no number) Scorpio Posteriorly Stabilized (PS) Total Knee System: named in the summary without a submission number
- (no number) Series 7000 Standard Tibial Tray: named in the summary without a submission number

## Most influential descendants
- K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component (2005), 90 descendants of its own
- 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
- K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert (2005), 48 descendants of its own

## Recalls of this device
- Dec 22, 2010 · Not classified · Z-1095-2011: Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should
- Sep 1, 2009 · Not classified · Z-2334-2010: A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP.
- Feb 17, 2006 · Not classified · Z-0910-2010: Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

## Indications for use
The Triathlon PS Total Knee system is comprised of femoral components, tibial trays, and tibial inserts that are intended to be used with the patellar components of the Duracon system in primary and revision total knee arthroplasty. The Triathlon PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. Specific indications and contraindications for the Triathlon PS Total Knee System are listed below: 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 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. The Triathlon PS Femoral Component and the Triathlon Primary Cemented Tibial Baseplate are intended to be implanted using bone cement.

Source page: https://510kreport.com/device/K031729
Methodology: https://510kreport.com/methodology