# K043374: Duracon Conversion and X-Small Symmetric Patella with Peri-Apatite Coating

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 16, 2005 after 70 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 Conversion and X-Small Symmetric Patella with Porous Coating for uncemented use: named in the summary without a submission number

## Indications for use
The Duracon Knee System Patella 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 without the use of bone cement.

Source page: https://510kreport.com/device/K043374
Methodology: https://510kreport.com/methodology