# K032163: Duracon Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 12, 2003 after 59 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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.
70 later devices descend from it; 4 cite it directly.
0 of 71 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® Total Knee System: 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
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert (2007), 40 descendants of its own
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 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

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0917-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0918-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0916-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

## Indications for use
The Duracon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, Irreparable fracture of the knee. These products are intended to achieve fixation with and without the use of bone cement.

Source page: https://510kreport.com/device/K032163
Methodology: https://510kreport.com/methodology