# K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 23, 2004 after 35 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040267 (2004). 1 ancestor in all.
48 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 2.

## Most influential descendants
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert (2007), 40 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
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own

## Indications for use
The Triathlon CR Size I tibial inserts are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. 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/K042883
Methodology: https://510kreport.com/methodology