# K163471: Kalitec Direct InSePtion™ MIS Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: Mar 16, 2017 after 94 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000319 (2000). 95 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133052: Affix (R) Next Gen Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 4.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 4.
- K140678: Cosmolock Pedicle Screw System, Kalitec Direct, LLC (2014) Summary page 4.

## Most influential descendants
- K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (2018), 5 descendants of its own
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (2018), 4 descendants of its own
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own
- K233735: ADIRA™ Lateral Plate System (2024), 0 descendants of its own

## Indications for use
The Kalitec Direct InSePtion™ MIS Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The Kalitec Direct InSePtion™ MIS Fixation System is not intended for standalone use, and is intended for use with autograft or allograft.

Source page: https://510kreport.com/device/K163471
Methodology: https://510kreport.com/methodology