Cleared Traditional

OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 (K140226) - FDA 510(k) Clearance

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

K140226 · Science For Biomaterials · Orthopedic device
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Jun 2014
Decision
125d
Days
Class 2
Risk

K140226 is an FDA 510(k) clearance for the OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Science For Biomaterials (Lourdes, FR). The FDA issued a Cleared decision on June 3, 2014 after a review of 125 days - within the typical 510(k) review window.

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 Science For Biomaterials devices

Submission Details

510(k) Number K140226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2014
Decision Date June 03, 2014
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 K140226.
BIOFOAM BONE WEDGE
K140531 · Wrightmedicaltechnologyinc · Jul 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417 · Wrightmedicaltechnologyinc · Jul 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · Arthrex, Inc. · Jul 2014
SALVATION 3DI PLATING SYSTEM
K140792 · Wrightmedicaltechnologyinc · May 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · Biomet, Inc. · May 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · Smith & Nephew, Inc. · May 2014