Cleared Traditional

K031050 - PCW PERCUTANEOUS COMPRESSION WIRE

K031050 is an FDA 510(k) clearance for PCW PERCUTANEOUS COMPRESSION WIRE, manufactured by Millennium Medical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K031050 · Millennium Medical Technologies, Inc. · Orthopedic device
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Jul 2003
Decision
103d
Days
Class 2
Risk

K031050 is an FDA 510(k) clearance for the PCW PERCUTANEOUS COMPRESSION WIRE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Millennium Medical Technologies, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on July 14, 2003 after a review of 103 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 Millennium Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K031050

510(k) Number K031050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2003
Decision Date July 14, 2003
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 122d · This submission: 103d
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 734
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K031050.
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · Osteomed LP · Aug 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · Walter Lorenz Surgical, Inc. · Aug 2003
BIORCI SCREW
K032224 · Smith & Nephew, Inc. · Aug 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · Walter Lorenz Surgical, Inc. · Jun 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · Inion , Ltd. · Jun 2003