Cleared Traditional

K182502 - Alteon Acetabular Cup System

K182502 is the FDA 510(k) clearance for Alteon Acetabular Cup System by Exactech, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 446
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