Cleared Traditional

K013888 - FIXATION (STEINMANN) PINS

K013888 is an FDA 510(k) clearance for FIXATION (STEINMANN) PINS, manufactured by Miltex, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 159-day FDA review.

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

FDA 510(k) Submission Details - K013888

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
Combination Product No
PCCP Authorized No
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.

HTY Device Classification - Class 2, Special Controls

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 107
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K013888.
K-FIX
K022597 · New Deal, S.A. · Nov 2002
NEWDEAL K WIRE
K022599 · New Deal, S.A. · Oct 2002
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · Mitek Products · Feb 2002
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa) · Apr 2001