Cleared Traditional

K170647 - Connector System

K170647 is the FDA 510(k) clearance for Connector System by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K170647 · Orthofix, Inc. · Orthopedic device
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May 2017
Decision
69d
Days
Class 2
Risk

K170647 is an FDA 510(k) clearance for the Connector System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on May 11, 2017 after a review of 69 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 Orthofix, Inc. devices

Submission Details

510(k) Number K170647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2017
Decision Date May 11, 2017
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K170647.
YUKON OCT Spinal System
K171444 · K2m, Inc. · Aug 2017
M.U.S.T. MINI Posterior Cervical Screws System
K171369 · Medacta International S.A. · Aug 2017
The Solstice OCT System
K170804 · Life Spine, Inc. · May 2017
The Cranial Fusion System
K162266 · Life Spine, Inc. · May 2017
Proficient™ Posterior Cervical Spine System
K162639 · Spine Wave, Inc. · Feb 2017
CastleLoc-S Posterior Cervical Fixation System
K162136 · L & K Biomed Co., Ltd. · Nov 2016