# K023724: Duracon CS Lipped Extra Small Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 3, 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: 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 no predicate by 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) Lipped Extra Small Tibial Insert is intended to be used with Duracon@Extra Small Universal and Cruciform tibial baseplates, Durac.on@ Cruciate Retaining femoral components and Duraconm 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. This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below: Indications Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, Irreparable Eracture of the knee Absolute contraindications include: Overt infection, Distant foci of infections (which may cause hematogenous spread to the implant site), Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram, Skeletally immature patients Cases where there is poor bone stock which would make the procedure unjustifiable, Conditions presenting an increased risk of failure include: Uncooperative patient or patient with neurological disorders who is incapable of following instructions, Osteoporosis, Metabolic disorders which may impair bone formation, Osteomalacia, and Previous arthrodesis

Source page: https://510kreport.com/device/K023724
Methodology: https://510kreport.com/methodology