Cleared Traditional

Smith & Nephew ACCORD™ Cable System (K223762) - FDA 510(k) Clearance

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

K223762 · Smith & Nephew · Orthopedic device
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May 2023
Decision
166d
Days
Class 2
Risk

K223762 is an FDA 510(k) clearance for the Smith & Nephew ACCORD™ Cable System. 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 (Cordova, US). The FDA issued a Cleared decision on May 30, 2023 after a review of 166 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K223762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2022
Decision Date May 30, 2023
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 699
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K223762.
TAMINA 3.5mm Proximal Humerus System
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ARIX Ankle System
K231441 · Jeil Medical Corporation · Jul 2023
APTUS® 3.5 TriLock Straight Plates
K230971 · Medartis AG · Jun 2023
KLS Martin LINOS Wrist System
K222624 · KLS-Martin L.P. · May 2023
ARIX Humerus System
K230938 · Jeil Medical Corporation · May 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
K222381 · Stryker GmbH · Apr 2023