Cleared Traditional

K200303 - Reform Pedicle Screw System

K200303 is the FDA 510(k) clearance for Reform Pedicle Screw System by Precision Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K200303 · Precision Spine · Orthopedic device
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May 2020
Decision
103d
Days
Class 2
Risk

K200303 is an FDA 510(k) clearance for the Reform Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Precision Spine (Pear, US). The FDA issued a Cleared decision on May 19, 2020 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Spine devices

Submission Details

510(k) Number K200303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2020
Decision Date May 19, 2020
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

The OrthoMedix Group, Inc.
John D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K200303.
Spinal Fixation System
K190408 · Shangdong Kangsheng Medical Devices Co., Ltd. · Jun 2020
Altus Spine Pedicle Screw System
K200322 · Altus Partners, LLC · Jun 2020
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
K193423 · Icotec AG · May 2020
Dymaxeon Spine System
K192930 · Back 2 Basics Direct, LLC · May 2020
CarboClear® II Pedicle Screw System
K200519 · CarboFix Orthopedics , Ltd. · Apr 2020
EXPEDIUM® Spine System
K200245 · Medos International S?rl · Apr 2020