Cleared Traditional

K082934 - EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM

K082934 is an FDA 510(k) clearance for EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, manufactured by Extremity Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K082934 · Extremity Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
204d
Days
Class 2
Risk

K082934 is an FDA 510(k) clearance for the EXTREMITY MEDICAL MIDFOOT 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 23, 2009 after a review of 204 days - an extended review 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: 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

FDA 510(k) Submission Details - K082934

510(k) Number K082934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date April 23, 2009
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 985
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K082934.
FUSION MEDICAL CANNULATED SCREW SYSTEM
K081122 · John Riccio · May 2009
FUSION MEDICAL STI
K081755 · John Riccio · May 2009
LIGAFIX INTERFACE SCREW
K090994 · Science For Biomaterials · May 2009
LATARJET CORTICAL SCREW SET
K083096 · Tag Medical Products · Apr 2009
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
K083792 · Medshape Solutions · Mar 2009
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
K081813 · U.S. Implant Solutions, LLC · Mar 2009