# K140738: Pass LP Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Nov 4, 2014 after 224 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: 9 generations back to K992147 (2000). 77 ancestors in all.
47 later devices descend from it; 9 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123138: Pass LP Spinal System, Medicrea International (2013) Summary page 4.

## Most influential descendants
- K202771: CD Horizon Spinal System (2020), 21 descendants of its own
- K211323: ASTRA Spine System (2021), 12 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K211981: KHEIRON® Spinal Fixation System (2022), 8 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: - Fracture - Dislocation - Failed previous fusion (Pseudarthrosis) - Spinal stenosis - Degenerative spondylolisthesis with objective evidence of neurological impairment - Spinal deformities 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 fate the attainment of a solid fusion. The PASS LP also includes hooks and 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. 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/K140738
Methodology: https://510kreport.com/methodology