Cleared Traditional

K932348 - ORTHOPEDIC SMOOTH PIN FIXATION

K932348 is the FDA 510(k) clearance for ORTHOPEDIC SMOOTH PIN FIXATION by Osteomed Corp.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K932348 · Osteomed Corp. · Orthopedic device
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Mar 1994
Decision
291d
Days
Class 2
Risk

K932348 is an FDA 510(k) clearance for the ORTHOPEDIC SMOOTH PIN FIXATION. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Osteomed Corp. (Fort Wayne, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 291 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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 Osteomed Corp. devices

Submission Details

510(k) Number K932348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1993
Decision Date March 01, 1994
Days to Decision 291 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
169d slower than avg
Panel avg: 122d · This submission: 291d
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 102
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K932348.
FIXATION PINS/WIRES
K943856 · Acu Med, Inc. · Jul 1995
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
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