Cleared Traditional

K120491 - DSS STABILIZATION SYSTEM-RIGID

K120491 is an FDA 510(k) clearance for DSS STABILIZATION SYSTEM-RIGID, manufactured by Paradigm Spine, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K120491 · Paradigm Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
82d
Days
Class 2
Risk

K120491 is an FDA 510(k) clearance for the DSS STABILIZATION SYSTEM-RIGID. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Paradigm Spine, LLC (Washington, US). The FDA issued a Cleared decision on May 9, 2012 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K120491

510(k) Number K120491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 17, 2012
Decision Date May 09, 2012
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K120491.
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · K2m, Inc. · Jun 2012
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
ARTS2 SPINAL FIXATION SYSTEM
K103573 · Advanced Medical Technologies · Dec 2011
LANCER PEDICLE SCREW SYSTEM
K110633 · Spinal Solutions, LLC · Dec 2011
XINGTM SPINE SYSTEM
K111995 · Implanova Co., Ltd. · Dec 2011