Cleared Traditional

K945670 - KIRSCHNER (K-WIRE), STEINMAN PINS

K945670 is an FDA 510(k) clearance for KIRSCHNER (K-WIRE), manufactured by Brasseler USA I, L.P.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K945670 · Brasseler USA I, L.P. · Orthopedic device
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Mar 1995
Decision
109d
Days
Class 2
Risk

K945670 is an FDA 510(k) clearance for the KIRSCHNER (K-WIRE), STEINMAN PINS. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Brasseler USA I, L.P. (Savannah, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 109 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 Brasseler USA I, L.P. devices

FDA 510(k) Submission Details - K945670

510(k) Number K945670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1994
Decision Date March 07, 1995
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 78
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K945670.
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K954630 · Depuy, Inc. · Dec 1995
CANNULATED PLUS HIP SCREW
K952640 · Wrightmedicaltechnologyinc · Jul 1995
CROSS PIN SCREW SYSTEM
K946228 · Depuy, Inc. · May 1995
ORTHOPEDIC THREADED PIN FIXATION
K932349 · Osteomed Corp. · Mar 1994
HAGIE PIN
K905347 · O'Tec Corp. · Jan 1991
STEINMAN PIN, THREADED
K905336 · O'Tec Corp. · Dec 1990