Cleared Traditional

K170571 - Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

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

K170571 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K170571

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.

HWC Device Classification - Class 2, Special Controls

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 952
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170571.
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · Extremity Medical, LLC · Jul 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
Cannulated Screws Neoortho
K162874 · Neoortho Produtos Ortopedicos S/A · Jun 2017
2-Piece Hammertoe Correction System
K162685 · Life Spine, Inc. · Jun 2017
Flower Bone Screw Set
K170687 · Flower Orthopedics Corporation · Jun 2017
ALLY(TM) Bone Screws
K170698 · Providence Medical Technology, Inc. · May 2017