Cleared Traditional

Reform Pedicle Screw System

K242297 · Precision Spine, Inc. · Orthopedic

Dec 2024

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K242297 is an FDA 510(k) clearance for the Reform Pedicle Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on December 17, 2024, 137 days after receiving the submission on August 2, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K242297 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2024
Decision Date	December 17, 2024
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.