# P090029: Prestige LP Cervical Disc

- Pathway: PMA
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jul 24, 2014 after 1,675 days
- Product code: MJO (Prosthesis, Intervertebral Disc)
- 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
- Mar 13, 2018 · Class II · Z-1641-2018: The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit

Source page: https://510kreport.com/device/P090029
Methodology: https://510kreport.com/methodology