Cleared Special

K013546 - MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

K013546 is an FDA 510(k) clearance for MODIFICATION TO: 1.5 BONE FIXATION KIT, manufactured by Bionx Implants, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 28-day FDA review.

K013546 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
28d
Days
Class 2
Risk

K013546 is an FDA 510(k) clearance for the MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Tampere, FI). The FDA issued a Cleared decision on November 21, 2001 after a review of 28 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

FDA 510(k) Submission Details - K013546

510(k) Number K013546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2001
Decision Date November 21, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 741
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K013546.
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa) · Dec 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa) · Dec 2001
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · New Deal, S.A. · Sep 2001
THE SPIN SNAP-OFF SCREW
K011946 · New Deal, S.A. · Aug 2001