Cleared Traditional

K001378 - BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

K001378 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 Traditional 510(k) pathway after a 88-day FDA review.

K001378 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
88d
Days
Class 2
Risk

K001378 is an FDA 510(k) clearance for the BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736. 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 July 28, 2000 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bionx Implants, Inc. devices

FDA 510(k) Submission Details - K001378

510(k) Number K001378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2000
Decision Date July 28, 2000
Days to Decision 88 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K001378.
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227 · Arthrex, Inc. · Jan 2001
MITEK CUFFTACK
K003076 · Mitek Products · Oct 2000
LACTOSORB MENISCAL SCREW
K002020 · Biomet Manufacturing, Inc. · Aug 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