Cleared Special

K020352 - SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE

K020352 is an FDA 510(k) clearance for SURGICAL DYNAMICS OGDEN SUTURE ANCHOR W..., manufactured by Unitedstates Surgical. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 22-day FDA review.

K020352 · Unitedstates Surgical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
22d
Days
Class 2
Risk

K020352 is an FDA 510(k) clearance for the SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Unitedstates Surgical (Norwalk, US). The FDA issued a Cleared decision on February 26, 2002 after a review of 22 days - a notably fast clearance 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. 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 Unitedstates Surgical devices

FDA 510(k) Submission Details - K020352

510(k) Number K020352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date February 26, 2002
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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 886
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K020352.
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · American Medical Systems, Inc. · Mar 2002
LORENZ SELF DRILLING SCREWS
K013954 · Walter Lorenz Surgical, Inc. · Feb 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · Karl Storz Endoscopy · Feb 2002
INION CPS BSSO SCREW
K020266 · Inion , Ltd. · Feb 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · Advanced Orthopaedic Solutions, Inc. · Feb 2002
SELF-COUNTERSINKING BONE SCREW
K013534 · Biomet Orthopedics, Inc. · Dec 2001