primaLOK FF

United States

primaLOK FF 25mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

DI: 00813210021952
Product codes
Submissions: K102438

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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2011-06-07	Z-0008-2012		Terminated	Two of the Implant Driver Assembly tips were reported to break during surgery.	—	clearance family

Regulatory clearances

510(k)K102438Substantially equivalent (SESE) · 2010-09-30clearance family

Predicate lineage

K102438

Cited as predicate by: K110170, K240085

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2018-08-29	NAI	No action indicated	Wenzel Spine, Inc.	0
2018-08-29	NAI	No action indicated	Wenzel Spine, Inc.	0
2016-03-11	VAI	Voluntary action indicated	Wenzel Spine, Inc.	7
2016-03-11	VAI	Voluntary action indicated	Wenzel Spine, Inc.	7
2012-10-15	NAI	No action indicated	Wenzel Spine, Inc.	0
2012-10-15	NAI	No action indicated	Wenzel Spine, Inc.	0

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