# K110497: Pass LP Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medicrea International
- Decided: Sep 26, 2011 after 216 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K992147 (2000). 33 ancestors in all.
133 later devices descend from it; 1 cites it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062136: Pass 2 Spinal System, Medicrea (2006) Summary page 1.
- K080099: Pass Spinal System, Medicrea Technologies (2008)
- K082069: Pass 2 Spinal System, Medicrea Technologies (2008) Summary page 1.
- K082577: Pass LP Spinal System, Medicrea Technologies (2008) Summary page 1.
- K083308: Pass LP Spinal System, Medicrea Technologies (2008) Summary page 1.
- K083810: Pass LP Spinal System, Medicrea Technologies (2009) Summary page 1.
- K100297: Pass LP Spinal System, Medicrea Technologies (2010) Summary page 1.

## Most influential descendants
- 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
- K161363: Arsenal Spinal Fixation System (2016), 75 descendants of its own
- K181677: Kodiak Spinal Fixation System (2018), 70 descendants of its own

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2458-2023: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

## Indications for use
The PASS LP 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: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors. The PASS LP Spinal System is also indicated for pedicle screw fixation 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. The PASS LP also includes hooks, rods and sacral/iliac screws 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 (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K110497
Methodology: https://510kreport.com/methodology