TOPS™ - 21 M

PREMIA SPINE LTD · Model 85858 · UDI-DI 07290014064010

QWK Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.

Recalls

Date	Firm	Reason
2025-07-16	PREMIA SPINE LTD	Potential for missing pins at tip of inserter.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.