Cleared Special

K172684 - Smith & Nephew

K172684 is the FDA 510(k) clearance for Smith & Nephew by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K172684 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2017
Decision
27d
Days
Class 2
Risk

K172684 is an FDA 510(k) clearance for the Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 3, 2017 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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. Low regulatory complexity profile. 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, Inc. devices

Submission Details

510(k) Number K172684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2017
Decision Date October 03, 2017
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 442
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K172684.
Smith & Nephew, Inc. REDAPT Augments
K171073 · Smith & Nephew, Inc. · Nov 2017
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K172251 · United Orthopedic Corporation · Oct 2017
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K162957 · United Orthopedic Corporation · Jul 2017
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K170444 · Microport Orthopedics, Inc. · Jun 2017
iTotal® Hip Replacement System
K162719 · Conformis, Inc. · Jun 2017