# K123138: Pass LP Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Feb 5, 2013 after 123 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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 K992147 (2000). 76 ancestors in all.
132 later devices descend from it; 6 cite it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110497: Pass LP Spinal System, Medicrea International (2011) Summary page 1.
- K111942: TSRH Spinal Systems, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.

## Most influential descendants
- 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
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own

## Indications for use
The PASS LP Spinal Systems include 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: * Fractures * Dislocation * Failed previous fusion (Pseudoarthrosis) * Spinal stenosis * Degenerative spondylolisthesis with objective evidence of neurological impairment * Spinal deformations such as scoliosis or kyphosis. * Loss of stability due to tumors. The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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 include hooks and rods and sacraliliac 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. Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K123138
Methodology: https://510kreport.com/methodology