Cleared Traditional

K933948 - ACUFEX ENDOBUTTON SYSTEM

K933948 is an FDA 510(k) clearance for ACUFEX ENDOBUTTON SYSTEM, manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K933948 · Acufex Microsurgical, Inc. · Orthopedic device
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Jul 1994
Decision
343d
Days
Class 2
Risk

K933948 is an FDA 510(k) clearance for the ACUFEX ENDOBUTTON SYSTEM. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on July 21, 1994 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K933948

510(k) Number K933948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1993
Decision Date July 21, 1994
Days to Decision 343 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 122d · This submission: 343d
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.