Cleared Traditional

CSS CANNULATED SCREW SYSTEM (K060428) - FDA 510(k) Clearance

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

K060428 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Mar 2006
Decision
14d
Days
Class 2
Risk

K060428 is an FDA 510(k) clearance for the CSS CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Akron, US). The FDA issued a Cleared decision on March 7, 2006 after a review of 14 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 Orthohelix Surgical Designs, Inc. devices

Submission Details

510(k) Number K060428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date March 07, 2006
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K060428.
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710 · Zimmer, Inc. · Apr 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736 · Smith & Nephew, Inc. · Apr 2006
ARTHREX ARTHOERESIS IMPLANT
K053543 · Arthrex, Inc. · Apr 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
K053344 · Smith & Nephew, Inc. · Feb 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · Arthrex, Inc. · Jan 2006
5TH METATARSAL FRACTURE SCREW
K053136 · Wrightmedicaltechnologyinc · Jan 2006