Cleared Traditional

K091577 - EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM

K091577 is the FDA 510(k) clearance for EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM by Extremity Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K091577 · Extremity Medical, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
52d
Days
Class 2
Risk

K091577 is an FDA 510(k) clearance for the EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM. 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 July 24, 2009 after a review of 52 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 K091577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date July 24, 2009
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
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 K091577.
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K091069 · Medacta International S.A. · Jun 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934 · Extremity Medical, LLC · Apr 2009