Cleared Traditional

K163487 - Ultima HA Coated Half Pins and Wire

K163487 is an FDA 510(k) clearance for Ultima HA Coated Half Pins and Wire, manufactured by Vilex IN Tennessee, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K163487

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Vilex, Inc.
Abraham Lavi

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDW Pin, Fixation, Threaded

All 81
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
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
K150661 · Citieffe S.R.L. · Jul 2015
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · Vilex, Inc. · Jul 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · Genossis, LLC · May 2014