Cleared Special

K000616 - SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

K000616 is an FDA 510(k) clearance for SMARTWEDGE ACL, manufactured by Bionx Implants, Ltd.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 28-day FDA review.

K000616 · Bionx Implants, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
28d
Days
Class 2
Risk

K000616 is an FDA 510(k) clearance for the SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Bionx Implants, Ltd. (Tampere, FI). The FDA issued a Cleared decision on March 23, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

FDA 510(k) Submission Details - K000616

510(k) Number K000616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2000
Decision Date March 23, 2000
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.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 220
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K000616.
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
K001378 · Bionx Implants, Inc. · Jul 2000
SYNTHES BIORESORBABLE SUTURE ANCHOR
K994161 · Synthes (Usa) · Jul 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506 · Arthrex, Inc. · May 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340 · Arthrex, Inc. · Jan 2000
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
K990987 · Arthrex, Inc. · Jan 2000
TITAN RC TACK
K994269 · Innovasive Devices, Inc. · Jan 2000
K000616 · SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
Download PDF FDA Summary Bionx Implants, Ltd.