# K001024: Pass Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: May 23, 2000 after 54 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
155 later devices descend from it; 6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020236: Modification to Pass Spinal System (2002), 150 descendants of its own
- K013442: Pass Spinal System (2002), 150 descendants of its own
- K013431: Pass Spinal System (2001), 150 descendants of its own
- K013191: Pass Spinal System (2001), 150 descendants of its own
- K012175: Pass Spinal System (2001), 150 descendants of its own

Source page: https://510kreport.com/device/K001024
Methodology: https://510kreport.com/methodology