Cleared Traditional

Gaudi Proximal Humerus Plate (K241296) - FDA 510(k) Clearance

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

K241296 · Netbiologics, LLC · Orthopedic device
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Jul 2024
Decision
76d
Days
Class 2
Risk

K241296 is an FDA 510(k) clearance for the Gaudi Proximal Humerus Plate. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Netbiologics, LLC (Lakewood Ranch, US). The FDA issued a Cleared decision on July 23, 2024 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Netbiologics, LLC devices

Submission Details

510(k) Number K241296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2024
Decision Date July 23, 2024
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K241296.
Freefix Forearm Plating System
K242055 · Skeletal Dynamics, Inc. · Aug 2024
Activmotion S
K241539 · Newclip Technics · Jul 2024
VOLT™ Proximal Humerus 3.5 Plating System
K233994 · Synthes GmbH · Jul 2024
KLS Martin Orthopedic Implants - MR Conditional
K241018 · KLS-Martin L.P. · Jul 2024
Versalock Rib and Sternum Plates System
K232829 · GM Dos Reis Industria e Comercio Ltda. · Jun 2024
Forma Medical Optimal Plating System
K234059 · Forma Medical, Inc. · Jun 2024