Cleared Traditional

K233696 - DePuy Synthes Retrograde Femoral Nail A...

K233696 is an FDA 510(k) clearance for DePuy Synthes Retrograde Femoral Nail A..., manufactured by DePuy Synthes. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K233696 · DePuy Synthes · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K233696

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.

HSB Device Classification - Class 2, Special Controls

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 365
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
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Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
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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