Cleared Traditional

K140226 - OTIS-C-PLUS

K140226 is an FDA 510(k) clearance for OTIS-C-PLUS, manufactured by Science For Biomaterials. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K140226 · Science For Biomaterials · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K140226

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.

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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140226.
AXSOS 3 TI LOCKING PLATE SYSTEM
K141121 · Stryker Trauma AG · Jun 2014
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
K141204 · Stryker Trauma AG · Jun 2014
ACUMED HAND FRACTURE SYSTEM
K141383 · Acumed, LLC · Jun 2014
VARIAX 2 COMPRESSION PLATING SYSTEM
K140565 · Stryker Trauma AG · May 2014
SALVATION 3DI PLATING SYSTEM
K140792 · Wrightmedicaltechnologyinc · May 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · Biomet, Inc. · May 2014