Cleared Traditional

K081934 - EXTREMITY MEDICAL COMPRESSION SCREW

K081934 is the FDA 510(k) clearance for EXTREMITY MEDICAL COMPRESSION SCREW by Extremity Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K081934 · Extremity Medical, LLC · Orthopedic device
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Aug 2008
Decision
53d
Days
Class 2
Risk

K081934 is an FDA 510(k) clearance for the EXTREMITY MEDICAL COMPRESSION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on August 29, 2008 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Extremity Medical, LLC devices

Submission Details

510(k) Number K081934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date August 29, 2008
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 620
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081934.
DARCO SMALL SCREW
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BIOPRO GO-EZ SCREW
K081149 · Biopro, Inc. · Aug 2008
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K081700 · Synthes (Usa) · Jul 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
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