Cleared Special

K020446 - MODIFICATION TO STRAIGHT-IN BONE SCREW ...

K020446 is the FDA 510(k) clearance for MODIFICATION TO STRAIGHT-IN BONE SCREW ... by American Medical Systems, Inc.. It is a Class 2 General & Plastic Surgery device (product code HWC) cleared through the Special 510(k) pathway after a 30-day FDA review.

K020446 · American Medical Systems, Inc. · General & Plastic Surgery device
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Mar 2002
Decision
30d
Days
Class 2
Risk

K020446 is an FDA 510(k) clearance for the MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.3040 - the FDA general and plastic surgery device 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all American Medical Systems, Inc. devices

Submission Details

510(k) Number K020446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date March 13, 2002
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 557
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K020446.
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K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001