# K032094: Passmed Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea
- Decided: Nov 14, 2003 after 130 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: 2 generations back to K001024 (2000). 6 ancestors in all.
149 later devices descend from it; 3 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001024: Pass Spinal System, Encore Orthopedics, Inc. (2000) Summary page 1.
- K012175: Pass Spinal System, Encore Orthopedics, Inc. (2001) Summary page 1.
- K013191: Pass Spinal System, Encore Orthopedics, Inc. (2001) Summary page 1.
- K013431: Pass Spinal System, Encore Orthopedics, Inc. (2001) Summary page 1.
- K013442: Pass Spinal System, Encore Orthopedics, Inc. (2002) Summary page 1.
- K020236: Modification to Pass Spinal System, Encore Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K062136: Pass 2 Spinal System (2006), 146 descendants of its own
- K110497: Pass LP Spinal System (2011), 133 descendants of its own
- K123138: Pass LP Spinal System (2013), 132 descendants of its own
- K142798: PASS LP Spinal System (2015), 84 descendants of its own
- K152968: Arsenal Spinal Fixation System (2015), 83 descendants of its own

## Indications for use
The PASSmed is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous hsion (pseudarthrosis). As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (Le., fracture or dislocation), spinal stenosis, deformities or curvatures (Le., scoliosis, kyphosis, andor lordosis), tumor, pseudoarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K032094
Methodology: https://510kreport.com/methodology