Cleared Traditional

K222465 - Tyber Medical Anatomical Plating System

K222465 is the FDA 510(k) clearance for Tyber Medical Anatomical 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 204-day FDA review.

K222465 · Tyber Medical, LLC · Orthopedic device
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Mar 2023
Decision
204d
Days
Class 2
Risk

K222465 is an FDA 510(k) clearance for the Tyber Medical Anatomical 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 March 7, 2023 after a review of 204 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 Tyber Medical, LLC devices

Submission Details

510(k) Number K222465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date March 07, 2023
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K222465.
WishBone Medical Plate and Screw System
K230527 · Wishbone Medical, Inc. · Mar 2023
KLS Martin Pure Pectus System
K221938 · KLS-Martin L.P. · Mar 2023
LOQTEQ® VA Elbow Plates 2.7/3.5 System
K230141 · Aap Implantate AG · Mar 2023
Tibia and Fibula System
K213059 · Auxein Medical Private Limited · Jan 2023
Advanced Bone Plate
K221150 · Double Medical Technology, Inc. · Jan 2023
Medline UNITE® Ankle Fusion Plating System
K222665 · Medline Industries, Inc. · Jan 2023