Cleared Traditional

K172495 - Reform POCT System

K172495 is the FDA 510(k) clearance for Reform POCT System by Precision Spine, Inc.. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

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
Combination Product No
PCCP Authorized No
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 Consultant

Empirical Testing Corp
Meredith L. May

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 - NKG Posterior Cervical Screw System

All 95
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K172495.
Proficient® Posterior Cervical Spine System
K181440 · Spine Wave, Inc. · Jul 2018
ASTRA-OCT Spine System
K181350 · Spinecraft, LLC · Jul 2018
VERTEX™ Reconstruction System
K180851 · Medtronic Sofamor Danek USA, Inc. · Apr 2018
NuVasive® VuePoint® II OCT System
K180198 · Nu Vasive, Incorporated · Mar 2018
The Solstice OCT System
K173047 · Life Spine, Inc. · Feb 2018
Centurion POCT System
K180025 · Orthofix, Inc. · Jan 2018