Cleared Special

NUGEN FX SCREW (K023022) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023022 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
23d
Days
Class 2
Risk

K023022 is an FDA 510(k) clearance for the NUGEN FX SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Blue Bell, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bionx Implants, Inc. devices

Submission Details

510(k) Number K023022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date October 04, 2002
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K023022.
MODULAR HEAD BONE SCREW
K022952 · Biomet, Inc. · Dec 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · Howmedica Osteonics Corp. · Oct 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · Smith & Nephew, Inc. · Oct 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · Arthrex, Inc. · Oct 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · Synthes (Usa) · Sep 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · Synthes (Usa) · Aug 2002