Cleared Traditional

K092420 - KRD1 PEDICLE SCREW SYSTEM

K092420 is the FDA 510(k) clearance for KRD1 PEDICLE SCREW SYSTEM by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K092420 · Spinefrontier, Inc. · Orthopedic device
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Nov 2009
Decision
105d
Days
Class 2
Risk

K092420 is an FDA 510(k) clearance for the KRD1 PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on November 19, 2009 after a review of 105 days - within the typical 510(k) review window.

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.

View all Spinefrontier, Inc. devices

Submission Details

510(k) Number K092420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2009
Decision Date November 19, 2009
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 119
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K092420.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · Spineart · Mar 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · Alphatec Spine, Inc. · Feb 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · Alphatec Spine, Inc. · Dec 2009
CASPIAN SPINAL SYSTEM
K092640 · K2m, Inc. · Nov 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · Alphatec Spine, Inc. · Jul 2009