Cleared Traditional

K182109 - REDAPT Modular Acetabular Shell

K182109 is the FDA 510(k) clearance for REDAPT Modular Acetabular Shell by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K182109 · Smith & Nephew, Inc. · Orthopedic device
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Nov 2018
Decision
105d
Days
Class 2
Risk

K182109 is an FDA 510(k) clearance for the REDAPT Modular Acetabular Shell. 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 November 16, 2018 after a review of 105 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K182109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date November 16, 2018
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 441
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K182109.
Alteon Acetabular Cup System
K182502 · Exactech, Inc. · Mar 2019
Provident II Hip Stem
K190276 · Stelkast, Inc. · Mar 2019
Delta TT Pro
K182099 · Lima Corporate S.P.A. · Dec 2018
REDAPT Porous Acetabular Shell
K181366 · Smith & Nephew, Inc. · Sep 2018
Latitud Hip Replacement System
K172857 · Meril Healthcare Pvt. , Ltd. · Jul 2018
Prime Acetabular Cup System
K180798 · Microport Orthopedics, Inc. · Jul 2018