Cleared Traditional

K123000 - INTEGRA TOTAL FOOT SYSTEMS

K123000 is an FDA 510(k) clearance for INTEGRA TOTAL FOOT SYSTEMS, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K123000 · Integra LifeSciences Corporation · Orthopedic device
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Dec 2012
Decision
85d
Days
Class 2
Risk

K123000 is an FDA 510(k) clearance for the INTEGRA TOTAL FOOT SYSTEMS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 21, 2012 after a review of 85 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 Integra LifeSciences Corporation devices

FDA 510(k) Submission Details - K123000

510(k) Number K123000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date December 21, 2012
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 1224
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123000.
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
K121826 · Ascension Orthopedics, Inc. · Feb 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · Smith & Nephew, Inc. · Jan 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122310 · Skeletal Dynamics, LLC · Jan 2013
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203 · Orthohelix Surgical Designs, Inc. · Dec 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495 · Aap Implantate AG · Dec 2012
CHECKMATE SMALL BONE FUSION SYSTEM
K122334 · Arthrosurface, Inc. · Nov 2012