# P050039: Novation Ceramic Articulation Hip System

- Pathway: PMA
- Applicant: Exactech, Inc.
- Decided: Jul 5, 2007 after 616 days
- Product code: MRA (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 12, 2016 · Class II · Z-1901-2016: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
- Apr 12, 2016 · Class II · Z-1905-2016: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
- Apr 12, 2016 · Class II · Z-1903-2016: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
- Apr 12, 2016 · Class II · Z-1900-2016: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
- Apr 12, 2016 · Class II · Z-1904-2016: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
- Apr 12, 2016 · Class II · Z-1902-2016: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Source page: https://510kreport.com/device/P050039
Methodology: https://510kreport.com/methodology