# P220002: TOPS™ System

- Pathway: PMA
- Applicant: Premia Spine, Ltd.
- Decided: Jun 15, 2023 after 484 days
- Product code: QWK (Prosthesis, Posterior Spinal Elements)
- 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
- Jul 16, 2025 · Class II · Z-2516-2025: Potential for missing pins at tip of inserter.

Source page: https://510kreport.com/device/P220002
Methodology: https://510kreport.com/methodology