# K021451: Duracon CS Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 18, 2002 after 165 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
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
0 of 42 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 AP Lipped Tibial Insert: named in the summary without a submission number

## 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 Duracon@CS (Condylar Stabilizing) Tibial Inserts are intended to be used with Duracon@Universal and Cruciform tibial baseplates, Duracon@Cruciate Retaining femoral components and DuraconB patellar components as part of a total knee system in primary cemented total knee arthroplasty. These Inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized. Because this insert does not incorporate a support post, it can accommodate the posterior cruciate ligament if it is present. More specific indications/contraindications are listed below: Indications Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascurar necrosis, Rheumatoid arthntis, Correction of functional deformity, Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, Irreparable fracture of the knee

Source page: https://510kreport.com/device/K021451
Methodology: https://510kreport.com/methodology