Cleared Traditional

K051044 - ARCTEC SEMIRIGID PLATING SYSTEM

K051044 is an FDA 510(k) clearance for ARCTEC SEMIRIGID PLATING SYSTEM, manufactured by Altiva Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K051044 · Altiva Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
165d
Days
Class 2
Risk

K051044 is an FDA 510(k) clearance for the ARCTEC SEMIRIGID PLATING SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Altiva Corp. (Charlotte, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 165 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 - K051044

510(k) Number K051044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2005
Decision Date October 07, 2005
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
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 K051044.
CONTOUR II SPINAL SYSTEM
K053070 · Altiva Corp. · Feb 2006
GII SPINAL FIXATION SYSTEM
K051089 · Co-Ligne AG · Oct 2005
NV CORMED SOLAS SPINAL SYSTEM
K051959 · Nv Cormed · Oct 2005
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697 · Medical Device Advisory Development Group · Sep 2005
XIA 4.5 SPINAL SYSTEM
K050461 · Stryker Spine · Jul 2005
HYDRALOK SYSTEM
K051216 · Altiva Corp. · Jul 2005
K051044 · ARCTEC SEMIRIGID PLATING SYSTEM
Download PDF FDA Summary Altiva Corp.