Cleared Traditional

K931836 - ACUFEX SMOOTH AND THREADED PINS

K931836 is the FDA 510(k) clearance for ACUFEX SMOOTH AND THREADED PINS by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K931836 · Acufex Microsurgical, Inc. · Orthopedic device
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Jun 1994
Decision
441d
Days
Class 2
Risk

K931836 is an FDA 510(k) clearance for the ACUFEX SMOOTH AND THREADED PINS. 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 June 28, 1994 after a review of 441 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 K931836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date June 28, 1994
Days to Decision 441 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
319d slower than avg
Panel avg: 122d · This submission: 441d
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 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K931836.
SPETZLER PIN
K954001 · Howmedica Corp. · Oct 1995
FIXATION PINS/WIRES
K943856 · Acu Med, Inc. · Jul 1995
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993
K-WIRE
K903264 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN
K903265 · Onyx Medical Corp. · Jul 1990