Cleared Special

K172785 - CONQUEST FN (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172785 · Smith & Nephew · Orthopedic device
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Dec 2017
Decision
98d
Days
Class 2
Risk

K172785 is an FDA 510(k) clearance for the CONQUEST FN. Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Smith & Nephew (Memphis, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew devices

Submission Details

510(k) Number K172785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2017
Decision Date December 22, 2017
Days to Decision 98 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDO Device, Fixation, Proximal Femoral, Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDO Device, Fixation, Proximal Femoral, Implant

All 22
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K172785.
OsteoCentric Integrated Hip Fastener System
K230764 · OsteoCentric Technologies · Apr 2023
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
K213126 · Smith & Nephew, Inc. · Sep 2022
OsteoCentric Integrated Hip Fastener System
K210247 · Osteocentric Technologies D.B.A. Osteocentric Trauma · Apr 2021
CONQUEST FN
K193029 · Smith & Nephew, Inc. · Feb 2020