# K070883: Duracon X3 CS Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 11, 2007 after 42 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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
- (no number) Triathlon® X3TM Tibial Inserts: named in the summary without a submission number
- (no number) Scorpio® X3TM Tibial Inserts: named in the summary without a submission number

## Indications for use
The Durcaon® 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/K070883
Methodology: https://510kreport.com/methodology