Cleared Traditional

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM (K060156) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060156 · I.T.S. Implantat-Technologie-Systeme GmbH · Orthopedic device
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Mar 2006
Decision
59d
Days
Class 2
Risk

K060156 is an FDA 510(k) clearance for the STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW 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 March 20, 2006 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.T.S. Implantat-Technologie-Systeme GmbH devices

Submission Details

510(k) Number K060156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2006
Decision Date March 20, 2006
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K060156.
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · Howmedica Osteonics Corp. · May 2006
POLYAX LOCKED PLATING SYSTEM
K060969 · DePuy Orthopaedics, Inc. · May 2006
STRYKER PLATING SYSTEM
K060798 · Howmedica Osteonics Corp. · Apr 2006
STRYKER PLATING SYSTEM
K060514 · Howmedica Osteonics Corp. · Mar 2006
ARTHREX TENSIONLOK
K052901 · Arthrex, Inc. · Dec 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · Synthes (Usa) · Dec 2005