Cleared Special

K013057 - BIOCUFF,C, MODELS 236018, 236028, 236036

K013057 is an FDA 510(k) clearance for BIOCUFF, 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 30-day FDA review.

K013057 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
30d
Days
Class 2
Risk

K013057 is an FDA 510(k) clearance for the BIOCUFF,C, MODELS 236018, 236028, 236036. 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 October 12, 2001 after a review of 30 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 - K013057

510(k) Number K013057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2001
Decision Date October 12, 2001
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K013057.
CUFFLOK ANCHOR
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SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · Smith & Nephew, Inc. · Nov 2001
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465 · Bonutti Research, Inc. · Oct 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · Bionx Implants, Inc. · Sep 2001
ARTHREX BIO-POST AND WASHER
K011495 · Arthrex, Inc. · Aug 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · Smith & Nephew, Inc. · Jun 2001
K013057 · BIOCUFF,C, MODELS 236018, 236028, 236036
Download PDF FDA Summary Bionx Implants, Inc.