Guided Pedicle System (GPS)

Primary DI: 00196852379552
Brand: Guided Pedicle System (GPS)
Company: Waypoint Orthopedics, Inc.
Model: W101
Device description: Single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to provide feedback to surgeons during pilot holedrilling for pedicle screw placement.
Published: 2026-01-16
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Product Codes#

Code, Name table
Code	Name
QWP	Optical Neurosurgical Nerve Locator

Code, Device, Specialty table
Code	Device	Specialty	Class
QWP	Optical Neurosurgical Nerve Locator	Ear, Nose, Throat	2

Submission, Supplement table
Submission	Supplement
K222106	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K222106	000	Waypoint GPS	Waypoint Orthopedics, Inc.	2023-05-12	QWP

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00196852379552	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00196852379552	00196852379552	196852379552	0196852379552

Term, Definition table
Term	Definition
Pedicle screw guide	A thin metal rod intended to guide the implantation of a pedicle screw during a minimally-invasive procedure, where it can also function as a guide for a gauge to provide a screw length measurement. It is inserted into the pedicle of a vertebra so that a cannulated pedicle screw is advanced over the guide, after a gauge is used over the guide to provide a measurement. This is a single-use device.

Method table
Method
Ethylene Oxide