# K240085: zLOCK Lumbar Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zygofix, Ltd.
- Decided: Apr 18, 2024 after 98 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K953076 (1997). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102438: Primalok Facet Fixation System, Osteomed LP (2010) Summary page 4.
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX), Providence Medical Technology, Inc. (2023) Summary page 4.

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

## Indications for use
The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients. The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zZLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.

Source page: https://510kreport.com/device/K240085
Methodology: https://510kreport.com/methodology