Cleared Traditional

K003077 - SMARTSCREW MODEL 222006...227510

K003077 is an FDA 510(k) clearance for SMARTSCREW MODEL 222006...227510, manufactured by Bionx Implants, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K003077 · Bionx Implants, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
205d
Days
Class 2
Risk

K003077 is an FDA 510(k) clearance for the SMARTSCREW MODEL 222006...227510. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bionx Implants, Ltd. (Bluebell, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 205 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 Bionx Implants, Ltd. devices

FDA 510(k) Submission Details - K003077

510(k) Number K003077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date April 26, 2001
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
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 811
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K003077.
MENISCUS ARROW SHEATH #CN1000A
K010554 · Bionx Implants, Inc. · May 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · Mitek Products · May 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc. · Mar 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
K003816 · Arthrex, Inc. · Mar 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · Smith & Nephew, Inc. · Mar 2001