Cleared Special

K170687 - Flower Bone Screw Set

K170687 is the FDA 510(k) clearance for Flower Bone Screw Set by Flower Orthopedics Corporation. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 91-day FDA review.

K170687 · Flower Orthopedics Corporation · Orthopedic device
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Jun 2017
Decision
91d
Days
Class 2
Risk

K170687 is an FDA 510(k) clearance for the Flower Bone Screw Set. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Flower Orthopedics Corporation (Horsham, US). The FDA issued a Cleared decision on June 6, 2017 after a review of 91 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. 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.

View all Flower Orthopedics Corporation devices

Submission Details

510(k) Number K170687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2017
Decision Date June 06, 2017
Days to Decision 91 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 553
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170687.
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