Cleared Traditional

K905336 - STEINMAN PIN

K905336 is an FDA 510(k) clearance for STEINMAN PIN, manufactured by O'Tec Corp.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K905336 · O'Tec Corp. · Orthopedic device
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Dec 1990
Decision
13d
Days
Class 2
Risk

K905336 is an FDA 510(k) clearance for the STEINMAN PIN, THREADED. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 13 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.

View all O'Tec Corp. devices

FDA 510(k) Submission Details - K905336

510(k) Number K905336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date December 11, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
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 60
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K905336.
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
RUSH PIN
K903261 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN, THREAD
K903266 · Onyx Medical Corp. · Jul 1990
FIXATOR PIN (EXTERNAL)
K881511 · Orthopedic Systems, Inc. · Jun 1988