Cleared Traditional

K051089 - GII SPINAL FIXATION SYSTEM

K051089 is an FDA 510(k) clearance for GII SPINAL FIXATION SYSTEM, manufactured by Co-Ligne AG. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K051089 · Co-Ligne AG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
181d
Days
Class 2
Risk

K051089 is an FDA 510(k) clearance for the GII SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Co-Ligne AG (Pleasant Hill, US). The FDA issued a Cleared decision on October 26, 2005 after a review of 181 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

FDA 510(k) Submission Details - K051089

510(k) Number K051089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2005
Decision Date October 26, 2005
Days to Decision 181 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
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K051089.
NUVASIVE SPHERX SYSTEM
K060225 · Nuvasive, Inc. · Apr 2006
GSS PEDICLE SCREW SYSTEM
K053573 · GS Medical Co., Ltd. · Mar 2006
CONTOUR II SPINAL SYSTEM
K053070 · Altiva Corp. · Feb 2006
NV CORMED SOLAS SPINAL SYSTEM
K051959 · Nv Cormed · Oct 2005
ARCTEC SEMIRIGID PLATING SYSTEM
K051044 · Altiva Corp. · Oct 2005
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697 · Medical Device Advisory Development Group · Sep 2005
K051089 · GII SPINAL FIXATION SYSTEM
Download PDF FDA Summary Co-Ligne AG