Cleared Traditional

K160756 - PASS OCT Spinal System

K160756 is an FDA 510(k) clearance for PASS OCT Spinal System, manufactured by Medicrea International SA. The device is a Class 2 Orthopedic device with product code NKG cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K160756 · Medicrea International SA · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
39d
Days
Class 2
Risk

K160756 is an FDA 510(k) clearance for the PASS OCT Spinal System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Medicrea International SA (Neyron, FR). The FDA issued a Cleared decision on April 26, 2016 after a review of 39 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 Medicrea International SA devices

FDA 510(k) Submission Details - K160756

510(k) Number K160756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2016
Decision Date April 26, 2016
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKG Device Classification - Class 2, Special Controls

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 103
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K160756.
PASS OCT Spinal System
K161149 · Medicrea International SA · Jul 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · Exactech, Inc. · Jun 2016
Certex Spinal Fixation System
K160428 · X-Spine Systems, Inc. · May 2016
Zimmer Virage OCT Spinal Fixation System
K153631 · Zimmer Spine, Inc. · Feb 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386 · Spineart · Jan 2016
VuePoint OCT System
K153336 · Nu Vasive, Incorporated · Jan 2016