Cleared Traditional

K232693 - Tyber Medical Distal Radius Plating System

K232693 is the FDA 510(k) clearance for Tyber Medical Distal Radius Plating System by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K232693 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
90d
Days
Class 2
Risk

K232693 is an FDA 510(k) clearance for the Tyber Medical Distal Radius Plating 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 Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on December 4, 2023 after a review of 90 days - within the typical 510(k) review window.

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 Tyber Medical, LLC devices

Submission Details

510(k) Number K232693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2023
Decision Date December 04, 2023
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K232693.
ARIX Ankle Distal Tibia System
K231887 · Jeil Medical Corporation · Dec 2023
Anatomical Plating System (various)
K232652 · Tyber Medical, LLC · Dec 2023
Valkyrie Thoracic Fixation System
K232515 · Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · Dec 2023
TriLEAP Plating System
K230591 · Crossroads Extremity Systems · Sep 2023
Exactech Equinoxe PHx Fracture System
K223933 · Exactech, Inc. · Sep 2023
KITE Distal Fibula Kit
K230623 · Intrauma S.P.A · Sep 2023