Cleared Special

K042966 - DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H

Also marketed or referenced as:
IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H

K042966 is an FDA 510(k) clearance for DUET SUTURE ANCHOR, manufactured by Linvatec Biomaterials, Ltd.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 22-day FDA review.

K042966 · Linvatec Biomaterials, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
22d
Days
Class 2
Risk

K042966 is an FDA 510(k) clearance for the DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Linvatec Biomaterials, Ltd. (Tampere, FI). The FDA issued a Cleared decision on November 19, 2004 after a review of 22 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 Linvatec Biomaterials, Ltd. devices

FDA 510(k) Submission Details - K042966

510(k) Number K042966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2004
Decision Date November 19, 2004
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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

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