Cleared Traditional

K833907 - CREIGHTON FIXATOR

K833907 is an FDA 510(k) clearance for CREIGHTON FIXATOR, manufactured by Patton Machine Co.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K833907 · Patton Machine Co. · Orthopedic device
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Feb 1984
Decision
87d
Days
Class 2
Risk

K833907 is an FDA 510(k) clearance for the CREIGHTON FIXATOR. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Patton Machine Co. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1984 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K833907

510(k) Number K833907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date February 09, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 92
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K833907.
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
K875021 · Buckman Co., Inc. · Dec 1987
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
K861766 · Howmedica Corp. · Jul 1986
PARTIALLY THREADED BONE FIX. PIN
K842293 · Warsaw Orthopedic, Inc. · Aug 1984
BROOKER EXTERNAL FIXATION FRAME
K840286 · Depuy, Inc. · Feb 1984
GOUFFON PIN, ADJUSTABLE
K760454 · Howmedica Corp. · Aug 1976
K833907 · CREIGHTON FIXATOR
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