Cleared Traditional

K032966 - THE ANSWER SCREW SUPPLEMENTATION SYSTEM

K032966 is an FDA 510(k) clearance for THE ANSWER SCREW SUPPLEMENTATION SYSTEM, manufactured by Simplicity Orthopedic Solutions, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K032966 · Simplicity Orthopedic Solutions, LLC · Orthopedic device
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Jan 2004
Decision
112d
Days
Class 2
Risk

K032966 is an FDA 510(k) clearance for the THE ANSWER SCREW SUPPLEMENTATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Simplicity Orthopedic Solutions, LLC (North Andover, US). The FDA issued a Cleared decision on January 13, 2004 after a review of 112 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 Simplicity Orthopedic Solutions, LLC devices

FDA 510(k) Submission Details - K032966

510(k) Number K032966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date January 13, 2004
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 122d · This submission: 112d
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 Peers - HWC Screw, Fixation, Bone

All 854
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K032966.
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
KOMPRESSOR SCREW SYSTEM
K040356 · Kinetikos Medical, Inc. · Mar 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · Acumed, LLC · Jan 2004
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · Linvatec Corp. · Dec 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
K033524 · Coapt Systems, Inc. · Dec 2003
SUBTALAR ARTHRORISIS IMPLANT
K032902 · Nexa Orthopedics, Inc. · Dec 2003