# K190376: PASS LP Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: May 2, 2019 after 72 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 395 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 397 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 4.
- K182240: PASS LP Spinal System, Medicrea International SA (2018) Summary page 4.
- K010720: TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2001) Summary page 4.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 4.
- K070530: Modification to Passmed Spinal System, Medicrea Technologies (2007) Summary page 4.

## Most influential descendants
- K213281: PASS LP™ Spinal System, CD Horizon™ Spinal System (2022), 0 descendants of its own

## Recalls of this device
- Jan 28, 2020 · Class II · Z-1473-2020: An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
- Jan 28, 2020 · Class II · Z-1472-2020: An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
- Nov 11, 2019 · Class II · Z-1234-2020: Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
- Sep 16, 2019 · Class II · Z-0827-2020: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
- Sep 16, 2019 · Class II · Z-0828-2020: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

## 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, pseudarthrosis, or failed previous fusion. Except for rod plates and caps for sacral 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/K190376
Methodology: https://510kreport.com/methodology