Cleared Traditional

K233423 - Tyber Medical Anatomical Plating System...

K233423 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 72-day FDA review.

K233423 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
72d
Days
Class 2
Risk

K233423 is an FDA 510(k) clearance for the Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag 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 21, 2023 after a review of 72 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 K233423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2023
Decision Date December 21, 2023
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K233423.
Medline UNITE Ancillary Foot Recon Plating System
K234031 · Medline Industires, LP · Jan 2024
Quick - Radius Disposable Set
K231684 · GM Dos Reis Industria e Comercio Ltda. · Jan 2024
SkyOPS™ Orthopedic Plate System
K233154 · Sky Surgical, LLC · Dec 2023
TM Plating System
K233017 · Tyber Medical, LLC · Dec 2023
Internal Locking Plate and Screw Fixation System
K232394 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · Dec 2023
ARIX Ankle Distal Tibia System
K231887 · Jeil Medical Corporation · Dec 2023