Cleared Traditional

K172495 - Reform® POCT System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172495 · Precision Spine, Inc. · Orthopedic device
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Apr 2018
Decision
236d
Days
Class 2
Risk

K172495 is an FDA 510(k) clearance for the Reform® POCT System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on April 11, 2018 after a review of 236 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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, Inc. devices

Submission Details

510(k) Number K172495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date April 11, 2018
Days to Decision 236 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 122d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of 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 Peers - NKG Posterior Cervical Screw System

All 116
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K172495.
CarboClear® Posterior Cervical Screw System
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CMORE® CT System
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Infinity™ OCT System
K253129 · Medtronic Sofamor Danek USA, Inc. · Oct 2025
ANAX™ OCT Spinal System
K251725 · Cg Medtech Co., Ltd. · Jun 2025
Sovereign Posterior Cervical System
K250866 · Met One Technologies, LLC · May 2025