# K020236: Modification to Pass Spinal System

- Pathway: 510(k) (Special)
- Applicant: Encore Orthopedics, Inc.
- Decided: Feb 14, 2002 after 22 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: 1 generation back to K001024 (2000). 1 ancestor in all.
150 later devices descend from it; 1 cites it directly.
0 of 152 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.

## Most influential descendants
- K032094: Passmed Spinal System (2003), 149 descendants of its own
- 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

## Indications for use
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lurmbar, and sacral spine: degenerative spondyiolisthesis with objective evidence of neurclogical impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fuslon 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. When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

Source page: https://510kreport.com/device/K020236
Methodology: https://510kreport.com/methodology