# K092803: Cardo Medical Align 360 Medialized Patella Component

- Pathway: 510(k) (Traditional)
- Applicant: Cardo Medical Corp.
- Decided: Dec 23, 2009 after 103 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
Longest line of descent: 2 generations back to K962152 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073120: Accin Patellofemoral System, Accelerated Innovation, LLC (2008) Summary page 1.
- K081127: Accin Total Knee System, Accelerated Innovation, LLC (2008) Summary page 1.

## Indications for use
When used with the Patello-femoral System: The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with: * Degenerative arthritis in the distal femur and patella; * A history of patellar dislocation or fracture; * Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain deformity or dysfunction persists. When used with the Total Knee System: The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of: * Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis; * Post-traumatic loss of knee joint configuration and function; * Moderate varus, valgus or flexion deformity in which the ligamentous structures can be. returned to adequate function and stability;, * Revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilized components: * Ligamentous instability requiring implant bearing surfaces with increased constraint; * Absent or non-functioning posterior cruciate ligament. The: patella components are single use only and intended for implantation with bone cement.

Source page: https://510kreport.com/device/K092803
Methodology: https://510kreport.com/methodology