Cleared Traditional

K123055 - SMITH & NEPHEW

K123055 is the FDA 510(k) clearance for SMITH & NEPHEW by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K123055 · Smith & Nephew, Inc. · Orthopedic device
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Jan 2013
Decision
116d
Days
Class 2
Risk

K123055 is an FDA 510(k) clearance for the SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 116 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K123055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date January 25, 2013
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 904
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