Cleared Traditional

K163487 - Ultima HA Coated Half Pins and Wire

K163487 is the FDA 510(k) clearance for Ultima HA Coated Half Pins and Wire by Vilex IN Tennessee, Inc.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K163487 · Vilex IN Tennessee, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
63d
Days
Class 2
Risk

K163487 is an FDA 510(k) clearance for the Ultima HA Coated Half Pins and Wire. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Vilex IN Tennessee, Inc. (Mcminnville, US). The FDA issued a Cleared decision on February 13, 2017 after a review of 63 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 Vilex IN Tennessee, Inc. devices

Submission Details

510(k) Number K163487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date February 13, 2017
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 53
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K163487.
Orthopedic Fixation Pin
K191803 · Tinavi (Anhui) Medical Technologies Co., Ltd. · Apr 2020
Temporary Fixation Pins
K192768 · Eisertech, LLC · Dec 2019
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · Aap Implantate AG · Oct 2013
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K130298 · Biopro, Inc. · Jun 2013
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012