Cleared Traditional

K932348 - ORTHOPEDIC SMOOTH PIN FIXATION

K932348 is an FDA 510(k) clearance for ORTHOPEDIC SMOOTH PIN FIXATION, manufactured by Osteomed Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K932348

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.

HTY Device Classification - Class 2, Special Controls

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 176
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
OTI ORTHOPEDIC FASTENER SYSTEM
K925301 · Osteo Technology, Inc. · Mar 1993
STEINMAN PIN
K905337 · O'Tec Corp. · Dec 1990