# K141398: Pass LP Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Jan 9, 2015 after 226 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 9 generations back to K992147 (2000). 86 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140449: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2014) Summary page 4.
- K123138: Pass LP Spinal System, Medicrea International (2013) Summary page 4.

## Most influential descendants
- K161627: PASS LP Spinal System (2016), 7 descendants of its own
- K162786: PASS LP Spinal System (2017), 6 descendants of its own
- K182239: OLYMPIC Posterior Spinal Fixation System (2018), 2 descendants of its own
- K182240: PASS LP Spinal System (2018), 2 descendants of its own
- K190376: PASS LP Spinal System (2019), 1 descendant of its own

## Recalls of this device
- Jun 27, 2019 · Class II · Z-0753-2020: It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a res

## Indications for use
The PASS LP Spinal System is a pedicle screw fixation system intended for 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or 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. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K141398
Methodology: https://510kreport.com/methodology