# K080099: Pass Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medicrea Technologies
- Decided: Apr 9, 2008 after 86 days
- Product code: MNI (Orthosis, Spinal Pedicle 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.
138 later devices descend from it; 5 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) similar previously cleared lumbar intervertebral body fusion devices: named in the summary without a submission number

## Most influential descendants
- K100297: Pass LP Spinal System (2010), 136 descendants of its own
- K083308: Pass LP Spinal System (2008), 135 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 2 Spinal System includes a pedicle 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). When used as a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

Source page: https://510kreport.com/device/K080099
Methodology: https://510kreport.com/methodology