# P060018: Prestige Cervical Disc System

- Pathway: PMA
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 16, 2007 after 423 days
- Product code: MJO (Prosthesis, Intervertebral Disc)
- 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
- Sep 4, 2007 · Not classified · Z-0142-2008: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be imporperly seated.
- Sep 4, 2007 · Not classified · Z-0141-2008: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- Sep 4, 2007 · Not classified · Z-0143-2008: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- Sep 4, 2007 · Not classified · Z-0138-2008: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- Sep 4, 2007 · Not classified · Z-0139-2008: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- Sep 4, 2007 · Not classified · Z-0140-2008: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

Source page: https://510kreport.com/device/P060018
Methodology: https://510kreport.com/methodology