Cleared Traditional

K221307 - Edge Upper Cervical System (FDA 510(k) Clearance)

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

K221307 · Spinal Simplicity, LLC · Orthopedic device
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Jul 2023
Decision
431d
Days
Class 2
Risk

K221307 is an FDA 510(k) clearance for the Edge Upper Cervical System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on July 10, 2023 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Spinal Simplicity, LLC devices

Submission Details

510(k) Number K221307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2022
Decision Date July 10, 2023
Days to Decision 431 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
309d slower than avg
Panel avg: 122d · This submission: 431d
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 K221307.
CarboClear® Posterior Cervical Screw System
K254045 · CarboFix Orthopedics , Ltd. · Mar 2026
Infinity™ OCT System
K254165 · Medtronic Sofamor Danek USA, Inc. · Jan 2026
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