Cleared Traditional

K932349 - ORTHOPEDIC THREADED PIN FIXATION (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932349 · Osteomed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 93
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K932349.
XT3 System
K260073 · Biodynamik, Inc. · Feb 2026
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316 · Meduloc, LLC · Oct 2025
XT3 System
K241357 · Biodynamik, Inc. · Jan 2025
MAVERICK Mini External Fixation System
K223112 · Smith & Nephew, Inc. · Dec 2022
MAVERICK External Fixation System
K213874 · Smith & Nephew, Inc. · Feb 2022
Steinmann Pins and Kirschner Wires
K211508 · Stryker GmbH · Oct 2021