Cleared Traditional

FIXATION (STEINMANN) PINS (K013888) - FDA 510(k) Clearance

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

K013888 · Miltex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
159d
Days
Class 2
Risk

K013888 is an FDA 510(k) clearance for the FIXATION (STEINMANN) PINS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Miltex, Inc. (Bethpage, US). The FDA issued a Cleared decision on May 1, 2002 after a review of 159 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 Miltex, Inc. devices

Submission Details

510(k) Number K013888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date May 01, 2002
Days to Decision 159 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 122d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 68
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K013888.
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa) · Apr 2001
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971 · Arthrex, Inc. · Aug 2000