Cleared Traditional

K193222 - Tyber Medical Anatomical Plating System

K193222 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 59-day FDA review.

K193222 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
59d
Days
Class 2
Risk

K193222 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 January 20, 2020 after a review of 59 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 Tyber Medical, LLC devices

Submission Details

510(k) Number K193222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2019
Decision Date January 20, 2020
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 K193222.
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
K193554 · Medartis AG · Feb 2020
Comus Locking Plate systems
K190842 · Jiangsu Trauhui Medical Instrument Co., Ltd. · Feb 2020
APTUS Clavicle System
K192984 · Medartis AG · Jan 2020
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
K193543 · In2bones USA, LLC · Jan 2020
MotoBAND CP Implant System
K193452 · Crossroads Extemity Systems, LLC · Jan 2020
TriMed ASET Foot Plating System
K192696 · TriMed, Inc. · Jan 2020