Cleared Traditional

K161058 - Cannulated Screw

K161058 is an FDA 510(k) clearance for Cannulated Screw, manufactured by Miami Device Solutions, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K161058 · Miami Device Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2016
Decision
105d
Days
Class 2
Risk

K161058 is an FDA 510(k) clearance for the Cannulated Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Miami Device Solutions, LLC (Miami, US). The FDA issued a Cleared decision on July 29, 2016 after a review of 105 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 Miami Device Solutions, LLC devices

FDA 510(k) Submission Details - K161058

510(k) Number K161058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2016
Decision Date July 29, 2016
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 Consultant

BioVera, Inc.
ROBERT POGGIE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K161058.
HammerTech Fixation System
K161449 · Fusion Orthopedics, LLC · Oct 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · In2bones Sas · Oct 2016
The Hammertoe Correction System
K153065 · Life Spine, Inc. · Aug 2016
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016
dynaMX(TM) Nitinol Compression Screw
K160427 · Mx Orthopedics, Corp. · Jun 2016