Cleared Traditional

K922766 - ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922766 · Acufex Microsurgical, Inc. · Orthopedic device
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Jul 1993
Decision
402d
Days
Class 2
Risk

K922766 is an FDA 510(k) clearance for the ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K922766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 02, 1992
Decision Date July 09, 1993
Days to Decision 402 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
280d slower than avg
Panel avg: 122d · This submission: 402d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 203
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