Cleared Traditional

K213126 - Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (FDA 510(k) Clearance)

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

K213126 · Smith & Nephew, Inc. · Orthopedic device
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Sep 2022
Decision
367d
Days
Class 2
Risk

K213126 is an FDA 510(k) clearance for the Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100.... Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 29, 2022 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K213126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date September 29, 2022
Days to Decision 367 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
245d slower than avg
Panel avg: 122d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDO Device, Fixation, Proximal Femoral, Implant
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.