Cleared Special

K003970 - CONTOUR LABRAL NAIL, MODEL 533520A

K003970 is an FDA 510(k) clearance for CONTOUR LABRAL NAIL, manufactured by Bionx Implants, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 21-day FDA review.

K003970 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
21d
Days
Class 2
Risk

K003970 is an FDA 510(k) clearance for the CONTOUR LABRAL NAIL, MODEL 533520A. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Tampere, FI). The FDA issued a Cleared decision on January 12, 2001 after a review of 21 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.

View all Bionx Implants, Inc. devices

FDA 510(k) Submission Details - K003970

510(k) Number K003970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2000
Decision Date January 12, 2001
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 184
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K003970.
SUPER REVO SUTURE ANCHOR
K003984 · Linvatec Corp. · Mar 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · Mitek Products · Feb 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · Synthes (Usa) · Feb 2001
LACTOSORB SCREW ANCHOR
K003273 · Biomet, Inc. · Jan 2001
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227 · Arthrex, Inc. · Jan 2001
MITEK CUFFTACK
K003076 · Mitek Products · Oct 2000