Cleared Traditional

K132893 - EDGE ORTHOPAEDICS BITE COMPRESSION SCREW

K132893 is an FDA 510(k) clearance for EDGE ORTHOPAEDICS BITE COMPRESSION SCREW, manufactured by Icon Orthopaedic Concepts Dba Edge Orthopaedics. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K132893 · Icon Orthopaedic Concepts Dba Edge Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2013
Decision
65d
Days
Class 2
Risk

K132893 is an FDA 510(k) clearance for the EDGE ORTHOPAEDICS BITE COMPRESSION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Icon Orthopaedic Concepts Dba Edge Orthopaedics (Boonton, US). The FDA issued a Cleared decision on November 20, 2013 after a review of 65 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 Icon Orthopaedic Concepts Dba Edge Orthopaedics devices

FDA 510(k) Submission Details - K132893

510(k) Number K132893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date November 20, 2013
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132893.
APTUS CANNULATED COMPRESSION SCREWS
K133460 · Medartis AG · Dec 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · Synthes USA Products, LLC · Dec 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
HAMMERTOE CORRECTION SYSTEM
K130859 · Arthrosurface, Inc. · Jul 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013