Cleared Traditional

K111370 - ODALYS PEDICLE SCREW SYSTEM

K111370 is an FDA 510(k) clearance for ODALYS PEDICLE SCREW SYSTEM, manufactured by Kalitec Direct, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K111370 · Kalitec Direct, LLC · Orthopedic device
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Sep 2011
Decision
128d
Days
Class 2
Risk

K111370 is an FDA 510(k) clearance for the ODALYS PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Kalitec Direct, LLC (Round Rock, US). The FDA issued a Cleared decision on September 21, 2011 after a review of 128 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 Kalitec Direct, LLC devices

FDA 510(k) Submission Details - K111370

510(k) Number K111370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date September 21, 2011
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 258
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K111370.
XINGTM SPINE SYSTEM
K111995 · Implanova Co., Ltd. · Dec 2011
DEVINE SPINAL SYSTEM
K111690 · Changzhou Orthmed Medical Instrument Co., Ltd. · Nov 2011
PASS LP SPINAL SYSTEM
K110497 · Medicrea International · Sep 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362 · Dio Medical Co., Ltd. · Jul 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · Solco Biomedical Co., Ltd. · Jun 2011
TIGER SPINE SYSTEM
K110321 · Corelink, LLC · May 2011