Cleared Traditional

K231339 - Tyber Medical Pin and Wire System (vari...

K231339 is the FDA 510(k) clearance for Tyber Medical Pin and Wire System (vari... by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K231339 · Tyber Medical, LLC · Orthopedic device
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Jul 2023
Decision
59d
Days
Class 2
Risk

K231339 is an FDA 510(k) clearance for the Tyber Medical Pin and Wire System (various). Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on July 6, 2023 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K231339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2023
Decision Date July 06, 2023
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 HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K231339.
Hammerdesis™ Interphalangeal Fusion System
K231147 · Intelivation · Sep 2023
OSSIOfiber® Cannulated Trimmable Fixation Nail
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Electro-Spec Steri-Caps
K231905 · Electro-Spec, Inc. · Aug 2023
Hammertoe Truss System (HTS)
K221283 · 4Web Medical, Inc. · Sep 2022
SECURE-LOCK
K220906 · Xiros, Ltd. · Jul 2022
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
K213982 · Pacific Instruments · Feb 2022