Cleared Traditional

K170571 - Tyber Medical BioTy(TM) Nanotopography ...

K170571 is the FDA 510(k) clearance for Tyber Medical BioTy(TM) Nanotopography ... by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K170571 · Tyber Medical, LLC · Orthopedic device
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Jun 2017
Decision
113d
Days
Class 2
Risk

K170571 is an FDA 510(k) clearance for the Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on June 20, 2017 after a review of 113 days - within the typical 510(k) review window.

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: 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 K170571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date June 20, 2017
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 574
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170571.
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Arthrex Compression Screws
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CAPTIVATE™ Compression Screws
K162825 · Globus Medical, Inc. · May 2017