Cleared Traditional

K932349 - ORTHOPEDIC THREADED PIN FIXATION

K932349 is an FDA 510(k) clearance for ORTHOPEDIC THREADED PIN FIXATION, manufactured by Osteomed Corp.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K932349 · Osteomed Corp. · Orthopedic device
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Mar 1994
Decision
291d
Days
Class 2
Risk

K932349 is an FDA 510(k) clearance for the ORTHOPEDIC THREADED PIN FIXATION. Classified as Pin, Fixation, Threaded (product code JDW), 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 - K932349

510(k) Number K932349 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.

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 84
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K932349.
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
HAGIE PIN
K905347 · O'Tec Corp. · Jan 1991
STEINMAN PIN, THREADED
K905336 · O'Tec Corp. · Dec 1990
KNOWLES PIN
K905344 · O'Tec Corp. · Dec 1990