# K150647: Polyscrew Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: New Era Orthopedics, LLC
- Decided: Apr 8, 2015 after 27 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 16 generations back to K853033 (1985). 248 ancestors in all.
No later device cites it as a predicate yet.
1 of 249 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141253: New Era Orthopaedics Polyscrew Pedicle Screw System, New Era Orthopaedics, LLC (2015) Summary page 5.
- K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 6.

## Recalls of this device
- Feb 13, 2017 · Class II · Z-2604-2018: This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were

## Indications for use
The New Era Orthopaedics Polyscrew Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K150647
Methodology: https://510kreport.com/methodology