Cleared Special

K170782 - Medline UNITE® Snap-Off Screws

K170782 is an FDA 510(k) clearance for Medline UNITE Snap-Off Screws, manufactured by Medline Industries, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 156-day FDA review.

K170782 · Medline Industries, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
156d
Days
Class 2
Risk

K170782 is an FDA 510(k) clearance for the Medline UNITE® Snap-Off Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 156 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K170782

510(k) Number K170782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2017
Decision Date August 18, 2017
Days to Decision 156 days
Submission Type Special
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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170782.
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K170038 · Fusion Orthopedics, LLC · Aug 2017
K170782 · Medline UNITE® Snap-Off Screws
Download PDF FDA Summary Medline Industries, I…