Cleared Special

K241218 - Tyber Medical Anatomical Plating System

K241218 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 Special 510(k) pathway after a 30-day FDA review.

K241218 · Tyber Medical, LLC · Orthopedic device
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May 2024
Decision
30d
Days
Class 2
Risk

K241218 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 May 31, 2024 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tyber Medical, LLC devices

Submission Details

510(k) Number K241218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2024
Decision Date May 31, 2024
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K241218.
APTUS Elbow Dorsal Olecranon Plates
K240613 · Medartis AG · Jun 2024
SIGNEX
K230546 · Osteonic Co., Ltd. · Jun 2024
Baby Gorilla/Gorilla Plating System
K241262 · Paragon 28, Inc. · Jun 2024
NeoSpan® Compression Implant System
K233089 · In2bones USA, LLC · May 2024
DePuy Synthes MatrixSTERNUM Fixation System
K233967 · Synthes GmbH · May 2024
XLO Brand of Locking Distal Humerus Plating System
K233873 · Ortho Life Systems Private Limited · Apr 2024