Cleared Traditional

K182502 - Alteon Acetabular Cup System

K182502 is an FDA 510(k) clearance for Alteon Acetabular Cup System, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K182502 · Exactech, Inc. · Orthopedic device
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Mar 2019
Decision
182d
Days
Class 2
Risk

K182502 is an FDA 510(k) clearance for the Alteon Acetabular Cup System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 13, 2019 after a review of 182 days - an extended review cycle.

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 Exactech, Inc. devices

FDA 510(k) Submission Details - K182502

510(k) Number K182502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2018
Decision Date March 13, 2019
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 540
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K182502.
Bencox Mirabo Cup Multi Hole
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MPACT Extension
K183582 · Medacta International S.A. · Mar 2019
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
K182468 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Mar 2019
Provident II Hip Stem
K190276 · Stelkast, Inc. · Mar 2019
Delta TT Pro
K182099 · Lima Corporate S.P.A. · Dec 2018
REDAPT Modular Acetabular Shell
K182109 · Smith & Nephew, Inc. · Nov 2018