Cleared Special

K993453 - MENISCUS ARROW, MODELS 531110, 531113, 531116

K993453 is an FDA 510(k) clearance for MENISCUS ARROW, 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 27-day FDA review.

K993453 · Bionx Implants, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
27d
Days
Class 2
Risk

K993453 is an FDA 510(k) clearance for the MENISCUS ARROW, MODELS 531110, 531113, 531116. 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 November 9, 1999 after a review of 27 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 - K993453

510(k) Number K993453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date November 09, 1999
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K993453.
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K993453 · MENISCUS ARROW, MODELS 531110, 531113, 531116
Download PDF FDA Summary Bionx Implants, Ltd.