Cleared Traditional

K945639 - SPETZLER PIN

K945639 is an FDA 510(k) clearance for SPETZLER PIN, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K945639 · Howmedica Corp. · Orthopedic device
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Apr 1995
Decision
149d
Days
Class 2
Risk

K945639 is an FDA 510(k) clearance for the SPETZLER PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 149 days - within the typical 510(k) review window.

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 Howmedica Corp. devices

FDA 510(k) Submission Details - K945639

510(k) Number K945639 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 16, 1994
Decision Date April 14, 1995
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
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 159
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K945639.
LACTOSORB BONE PIN
K953194 · Biomet, Inc. · Oct 1995
SPETZLER PIN
K954001 · Howmedica Corp. · Oct 1995
FIXATION PINS/WIRES
K943856 · Acu Med, Inc. · Jul 1995
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993