# K102438: Primalok Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Sep 30, 2010 after 35 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K020411 (2002). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.
- K082795: Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant, Interventional Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K240085: zLOCK Lumbar Facet Fixation System (2024), 2 descendants of its own
- K242527: The Karma® Fixation System (2025), 0 descendants of its own
- K242650: zLOCK Lumbar Facet Fixation System (2024), 0 descendants of its own
- K110170: Raptor Facet Fixation System (2011), 0 descendants of its own

## Recalls of this device
- Jun 7, 2011 · Not classified · Z-0008-2012: Two of the Implant Driver Assembly tips were reported to break during surgery.

## Indications for use
The 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 Li to Si 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 disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis 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 pedlicle. 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.

Source page: https://510kreport.com/device/K102438
Methodology: https://510kreport.com/methodology