# K182502: Alteon Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 13, 2019 after 182 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 127 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component, Exactech, Inc. (1999) Summary page 4.
- K070479: Exactech Novation Crown Cup and Liners, Exactech, Inc. (2007) Summary page 4.
- K100269: Novation Crown Cup GXL Liners, Exactech, Inc. (2010) Summary page 4.
- K173583: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners, Exactech, Inc. (2018) Summary page 4.

## Most influential descendants
- K210614: BENCOX Mirabo Z Cup Cortinium (2022), 1 descendant of its own
- K223223: BENCOX Mirabo Z Cup Cortinium (2023), 0 descendants of its own

## Recalls of this device
- Dec 31, 2024 · Class II · Z-1167-2025: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- Nov 21, 2023 · Class II · Z-0578-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

## Indications for use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. » Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. » Press-fit femoral stems and acetabular cups are intended for press-fit fixation. » Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K182502
Methodology: https://510kreport.com/methodology