Cleared Traditional

K093770 - EXTREMITY MEDICAL SCREW SYSTEM

K093770 is the FDA 510(k) clearance for EXTREMITY MEDICAL 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 141-day FDA review.

K093770 · Extremity Medical, LLC · Orthopedic device
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Apr 2010
Decision
141d
Days
Class 2
Risk

K093770 is an FDA 510(k) clearance for the EXTREMITY MEDICAL 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 April 28, 2010 after a review of 141 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 Extremity Medical, LLC devices

Submission Details

510(k) Number K093770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2009
Decision Date April 28, 2010
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 K093770.
DARCO HEADED CANNULATED SCREW
K100359 · Wrightmedicaltechnologyinc · Jun 2010
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K101030 · Biopro, Inc. · Jun 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · Smith & Nephew, Inc. · May 2010
OPUS SPEEDSCREW SYSTEM
K100457 · Arthrocare Corp. · Mar 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · TriMed, Inc. · Mar 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · Depuy Mitek, A Johnson & Johnson Company · Mar 2010