Cleared Traditional

KITE Distal Fibula Kit (K230623) - FDA 510(k) Clearance

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

K230623 · Intrauma S.P.A · Orthopedic device
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Sep 2023
Decision
179d
Days
Class 2
Risk

K230623 is an FDA 510(k) clearance for the KITE Distal Fibula Kit. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Intrauma S.P.A (Rivoli (To), IT). The FDA issued a Cleared decision on September 1, 2023 after a review of 179 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 Intrauma S.P.A devices

Submission Details

510(k) Number K230623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2023
Decision Date September 01, 2023
Days to Decision 179 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
57d slower than avg
Panel avg: 122d · This submission: 179d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K230623.
Tyber Medical Distal Radius Plating System
K232693 · Tyber Medical, LLC · Dec 2023
TriLEAP Plating System
K230591 · Crossroads Extremity Systems · Sep 2023
Exactech Equinoxe PHx Fracture System
K223933 · Exactech, Inc. · Sep 2023
TriMed Clavicle Fixation System
K230805 · TriMed, Inc. · Sep 2023
Distal Elbow Plating System
K231623 · Skeletal Dynamics, Inc. · Aug 2023
APS Metal Plate & Screw System
K223150 · A Plus Biotechnology Co., Ltd. · Aug 2023