# K100354: Primal OK Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Aug 17, 2010 after 186 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- 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: 3 generations back to K032037 (2003). 5 ancestors in all.
37 later devices descend from it; 8 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043053: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 1.

## Most influential descendants
- K131238: Affix Spinous Process Plate System (2013), 30 descendants of its own
- K133052: Affix (R) Next Gen Spinous Process Plate System (2013), 18 descendants of its own
- K122509: Vertiflex Spinous Process Fixation Plate (2012), 18 descendants of its own
- K132968: Univise Spinous Process Fixation Plate (35MM, 40MM) (2013), 12 descendants of its own
- K140046: Spinous Process Fusion (SPF) Plate (2015), 9 descendants of its own

## Indications for use
The Primal-OK TM sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti-Si). It is intended for plate fixation/attachment to spinous process 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 PrimaLOK Tmsp Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

Source page: https://510kreport.com/device/K100354
Methodology: https://510kreport.com/methodology