Cleared Traditional

K122994 - INTRAMEDULLARY NAIL SYSTEM

K122994 is an FDA 510(k) clearance for INTRAMEDULLARY NAIL SYSTEM, manufactured by Weigao Orthopaedic Device Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K122994 · Weigao Orthopaedic Device Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
197d
Days
Class 2
Risk

K122994 is an FDA 510(k) clearance for the INTRAMEDULLARY NAIL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Weigao Orthopaedic Device Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 12, 2013 after a review of 197 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

FDA 510(k) Submission Details - K122994

510(k) Number K122994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date April 12, 2013
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K122994.
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K123487 · Gold Standard Orthopaedics, LLC · Mar 2013
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K123164 · Spinefrontier, Inc. · Feb 2013
MEGA 5.5 SPINE SYSTEM
K123476 · Lsk Biopartners, Inc. · Jan 2013
K122994 · INTRAMEDULLARY NAIL SYSTEM
Download PDF FDA Summary Weigao Orthopaedic De…