# K112493: Pass LP Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medicrea International
- Decided: Nov 21, 2011 after 84 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
Longest line of descent: 8 generations back to K841189 (1984). 49 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 51 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) Summary page 1.
- K080822: VU Apod Intervertabral Body Fusion Device, Theken Spine, LLC (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.
- K012871: Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177, Interpore Cross Intl. (2001) Summary page 1.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K980485: Isola Spinal System, Acromed Corp. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K153413: PASS LP Spinal System (2016), 0 descendants of its own

## Indications for use
The PASS LP Spinal System includes a pedlicle 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 br 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 L5-51 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, traumna (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordlosis), tumor, pseudoarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K112493
Methodology: https://510kreport.com/methodology