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Alteon Acetabular Cup System

by Exactech, Inc.

510(k) K182502

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182502 Date13 Mar 2019ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1167-2025 FDA Class II initiated 31 Dec 2024

    Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

    • Ongoing Z-0578-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alteon Acetabular Cup System is a metallic acetabular cup designed for total hip arthroplasty. It features an Asymmatrix porous coating to enhance osseointegration and is paired with ultra-high-molecular-weight polyethylene (UHMWPE) liners blended with vitamin E to improve wear resistance and longevity. This system is intended for use in primary and revision hip replacements, providing structural support and stability to the acetabulum.

The system is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K182502) as substantially equivalent to a predicate device. It is intended for use in controlled surgical environments, adhering to standard orthopedic protocols. The metallic construction and porous coating require careful handling and sterilization per manufacturer guidelines. No additional regulatory markings beyond the FDA clearance are specified.

Other devices from Exactech, Inc.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of hip surgeries is the Alteon Acetabular Cup System intended for, and how does its design support those procedures?

    The Alteon Acetabular Cup System is designed for both primary and revision total hip arthroplasty. Its Asymmatrix porous coating enhances osseointegration, helping the implant bond securely to the patient’s bone for long-term stability. The system also pairs with vitamin E-infused UHMWPE liners, which reduce wear and extend the implant’s lifespan—critical benefits for revision cases where durability is essential.

  • Is the Alteon Acetabular Cup System reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

    The Alteon Acetabular Cup System is sterile and intended for single-use only. Since it is metallic with a porous coating, it cannot be reprocessed or sterilized for reuse. To preserve sterility, it must be handled using aseptic techniques in a controlled surgical environment, following Exactech’s handling and preparation guidelines.

  • What materials are used in the Alteon Acetabular Cup System, and how do they contribute to its performance?

    The system features a metallic acetabular cup with an Asymmatrix porous coating to promote bone integration, and it is paired with ultra-high-molecular-weight polyethylene (UHMWPE) liners infused with vitamin E. The porous coating improves stability by encouraging bone growth, while the vitamin E-enhanced UHMWPE reduces wear and extends the implant’s longevity, making it suitable for demanding procedures.

  • How is the Alteon Acetabular Cup System regulated in the U.S., and what does the FDA clearance indicate about its safety and effectiveness?

    The Alteon Acetabular Cup System holds FDA 510(k) clearance (K182502), meaning it has been determined substantially equivalent to a predicate device already on the market. This clearance indicates that the FDA has reviewed its design, manufacturing processes, and clinical rationale and found it to meet regulatory standards for safety and performance in total hip arthroplasty. The clearance does not imply approval for specific clinical outcomes but confirms compliance with U.S. regulatory requirements.