Cleared Traditional

INION CPS/OTPS FREEDOMPLATE (K063410) - FDA 510(k) Clearance

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

K063410 · Inion , Ltd. · Orthopedic device
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Jan 2007
Decision
71d
Days
Class 2
Risk

K063410 is an FDA 510(k) clearance for the INION CPS/OTPS FREEDOMPLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on January 23, 2007 after a review of 71 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 Inion , Ltd. devices

Submission Details

510(k) Number K063410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date January 23, 2007
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K063410.
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
K070946 · Synthes (Usa) · Jun 2007
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
K070208 · Synthes (Usa) · Mar 2007
STRYKER FOOT PLATING SYSTEM
K063875 · Howmedica Osteonics Corp. · Mar 2007
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049 · Synthes (Usa) · Dec 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303 · Zimmer, Inc. · Nov 2006
PROFYLE SYSTEM
K062498 · Howmedica Osteonics Corp. · Oct 2006