Cleared Traditional

DePuy Synthes Retrograde Femoral Nail Advanced System (K233696) - FDA 510(k) Clearance

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

K233696 · DePuy Synthes · Orthopedic device
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Aug 2024
Decision
258d
Days
Class 2
Risk

K233696 is an FDA 510(k) clearance for the DePuy Synthes Retrograde Femoral Nail Advanced System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by DePuy Synthes (West Chester, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 258 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 DePuy Synthes devices

Submission Details

510(k) Number K233696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2023
Decision Date August 01, 2024
Days to Decision 258 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
136d slower than avg
Panel avg: 122d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 258
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K233696.
Affixus Tibial and Antegrade Femoral Nailing System
K241651 · Zimmer, Inc. · Sep 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
K230071 · Tdm Co., Ltd. · Aug 2024
Phantom Fibula Nail System
K234128 · Paragon 28, Inc. · Aug 2024
Fitbone Trochanteric
K233867 · Orthofix Srl · Jun 2024
RODEO Telescopic Nail
K232648 · Orthofix Srl · May 2024
Vertex Hip Fracture Nailing System
K233910 · Orthoxel Dac · Apr 2024