# K040267: Triathlon Cruciate Retaining (CR) Total Knee

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 5, 2004 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
163 later devices descend from it; 17 cite it directly.
0 of 164 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 PS Total Knee System: named in the summary without a submission number
- (no number) Duracon CR Femoral Component: named in the summary without a submission number
- (no number) Scorpio CR Femoral Component: named in the summary without a submission number
- (no number) Duracon A/P Lipped Tibial Insert: named in the summary without a submission number
- (no number) Duracon Symmetric Patellar Component: named in the summary without a submission number
- (no number) Duracon Asymmetric Patellar Component: named in the summary without a submission number
- (no number) Kinemax All Polyethylene Patella: named in the summary without a submission number

## Most influential descendants
- K051380: Triathlon Press-Fit Total Knee System (2005), 54 descendants of its own
- K123486: Triathlon Tritanium Tibial Baseplate (2013), 51 descendants of its own
- K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert (2004), 48 descendants of its own
- K101499: Journey CR Knee System (2010), 45 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene Patellar components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously released Triathlon PS Femoral component in situations where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications 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. Contraindications * Any active or suspected latent infection in or about the knee joint. * Distant foci of infection which may cause hematogenous spread to the implant site * Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis. * Skeletal immaturity. * Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. * Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself

Source page: https://510kreport.com/device/K040267
Methodology: https://510kreport.com/methodology