Cleared Traditional

K103573 - ARTS2 SPINAL FIXATION SYSTEM

K103573 is an FDA 510(k) clearance for ARTS2 SPINAL FIXATION SYSTEM, manufactured by Advanced Medical Technologies. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K103573 · Advanced Medical Technologies · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
387d
Days
Class 2
Risk

K103573 is an FDA 510(k) clearance for the ARTS2 SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Advanced Medical Technologies (Round Rock, US). The FDA issued a Cleared decision on December 28, 2011 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K103573

510(k) Number K103573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date December 28, 2011
Days to Decision 387 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
265d slower than avg
Panel avg: 122d · This submission: 387d
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 K103573.
S 100 PEDICLE SCREW SYSTEM
K111940 · Renovis Surgical Technologies, LLC · May 2012
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
K120353 · Bm Korea Co., Ltd. · May 2012
DSS STABILIZATION SYSTEM-RIGID
K120491 · Paradigm Spine, LLC · May 2012
LANCER PEDICLE SCREW SYSTEM
K110633 · Spinal Solutions, LLC · Dec 2011
XINGTM SPINE SYSTEM
K111995 · Implanova Co., Ltd. · Dec 2011
DEVINE SPINAL SYSTEM
K111690 · Changzhou Orthmed Medical Instrument Co., Ltd. · Nov 2011
K103573 · ARTS2 SPINAL FIXATION SYSTEM
Download PDF FDA Summary Advanced Medical Tech…