Cleared Traditional

K113014 - CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS

K113014 is an FDA 510(k) clearance for CLAW II POLYAXIAL COMPRESSION SYSTEM AN..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K113014 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 2012
Decision
112d
Days
Class 2
Risk

K113014 is an FDA 510(k) clearance for the CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 31, 2012 after a review of 112 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K113014

510(k) Number K113014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date January 31, 2012
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 1254
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113014.
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K113048 · Orthohelix Surgical Designs, Inc. · Jan 2012
NCB STRAIGHT NARROW SHAFT PLATES
K113718 · Zimmer GmbH · Jan 2012
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
K113318 · Acute Innovations, LLC · Jan 2012