Cleared Traditional

K140875 - OPTOSSOL COMPRESSION DEVICE SYSTEM

K140875 is an FDA 510(k) clearance for OPTOSSOL COMPRESSION DEVICE SYSTEM, manufactured by Genossis, LLC. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K140875 · Genossis, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
56d
Days
Class 2
Risk

K140875 is an FDA 510(k) clearance for the OPTOSSOL COMPRESSION DEVICE SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Genossis, LLC (Newburyport, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 56 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.

FDA 510(k) Submission Details - K140875

510(k) Number K140875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2014
Decision Date May 30, 2014
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 Peers - JDW Pin, Fixation, Threaded

All 90
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K140875.
Ultima HA Coated Half Pins and Wire
K163487 · Vilex IN Tennessee, Inc. · Feb 2017
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
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
K140875 · OPTOSSOL COMPRESSION DEVICE SYSTEM
Download PDF FDA Summary Genossis, LLC