Cleared Traditional

Posterior Cervical Spine System (K233078) - FDA 510(k) Clearance

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

K233078 · Double Medical Technology, Inc. · Orthopedic device
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Nov 2023
Decision
58d
Days
Class 2
Risk

K233078 is an FDA 510(k) clearance for the Posterior Cervical Spine System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on November 22, 2023 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Double Medical Technology, Inc. devices

Submission Details

510(k) Number K233078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date November 22, 2023
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 81
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K233078.
CarboClear® Posterior Cervical Screw System
K233989 · CarboFix Orthopedics , Ltd. · Mar 2024
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
K231850 · Globus Medical, Inc. · Mar 2024
Statera-C™ Spinal System
K233332 · K&J Consulting Corp. · Nov 2023
SYMPHONY OCT System
K233366 · Medos International SARL · Nov 2023
VySpan™ PCT System
K232167 · Vy Spine, LLC · Sep 2023
NorthStar OCT System
K231654 · Seaspine, Inc. · Aug 2023