# P000057: Ascension MCP

- Pathway: PMA
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 19, 2001 after 325 days
- Product code: NEG (Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis)
- Device class: 3
- Recalls of this device: 1 (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
- Oct 31, 2002 · Not classified · Z-0550-03: Literature approved for international distribution only was distributed domestically.

Source page: https://510kreport.com/device/P000057
Methodology: https://510kreport.com/methodology