Cleared Traditional

K152686 - CONQUEST FN

K152686 is an FDA 510(k) clearance for CONQUEST FN, manufactured by Smith & Nephew. The device is a Class 2 Orthopedic device with product code JDO cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K152686 · Smith & Nephew · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
181d
Days
Class 2
Risk

K152686 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 March 17, 2016 after a review of 181 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Smith & Nephew devices

FDA 510(k) Submission Details - K152686

510(k) Number K152686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2015
Decision Date March 17, 2016
Days to Decision 181 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 slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDO Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K152686.
OsteoCentric Integrated Hip Fastener System
K210247 · Osteocentric Technologies D.B.A. Osteocentric Trauma · Apr 2021
CONQUEST FN
K193029 · Smith & Nephew, Inc. · Feb 2020
THP Hip Fracture Plating System
K173826 · Biomet, Inc. · Feb 2018
TSP HIP FRACTURE PLATING SYSTEM
K140018 · Biomet, Inc. · Apr 2014
HIPLOC COMPRESSION HIP SCREW
K080685 · Biomet Manufacturing, Inc. · Aug 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · Smith & Nephew, Inc. · Apr 2008