Cleared Traditional

EDGELOCK (K093900) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093900 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Feb 2010
Decision
61d
Days
Class 2
Risk

K093900 is an FDA 510(k) clearance for the EDGELOCK. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Akron, US). The FDA issued a Cleared decision on February 17, 2010 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Orthohelix Surgical Designs, Inc. devices

Submission Details

510(k) Number K093900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date February 17, 2010
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K093900.
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111 · Zimmer, Inc. · Apr 2010
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · Synthes (Usa) · Apr 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · Synthes (Usa) · Mar 2010
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474 · DePuy Orthopaedics, Inc. · Feb 2010
EVOLVE EPS ORTHOLOC
K100146 · Wrightmedicaltechnologyinc · Feb 2010
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
K093433 · Howmedica Osteonics Corp. · Jan 2010