Cleared Traditional

K092420 - KRD1 PEDICLE SCREW SYSTEM

K092420 is an FDA 510(k) clearance for KRD1 PEDICLE SCREW SYSTEM, manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K092420

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
Combination Product No
PCCP Authorized No
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.

MNI Device Classification - Class 2, Special Controls

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 226
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
MODIFICATION TO: PSS SYSTEM
K092128 · Spinal USA · Sep 2009