Cleared Traditional

K093868 - I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM

K093868 is an FDA 510(k) clearance for I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM, manufactured by I.T.S. Implantat-Technologie-Systeme GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K093868 · I.T.S. Implantat-Technologie-Systeme GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
231d
Days
Class 2
Risk

K093868 is an FDA 510(k) clearance for the I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by I.T.S. Implantat-Technologie-Systeme GmbH (Prior Lake, US). The FDA issued a Cleared decision on August 5, 2010 after a review of 231 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 I.T.S. Implantat-Technologie-Systeme GmbH devices

FDA 510(k) Submission Details - K093868

510(k) Number K093868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2009
Decision Date August 05, 2010
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1064
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K093868.
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ASCENSION TOTAL PLATE SYSTEM
K100502 · Ascension Orthopedics, Inc. · Aug 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010