# K100269: Novation Crown Cup GXL Liners

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: May 27, 2010 after 118 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931641 (1994). 21 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070479: Exactech Novation Crown Cup and Liners, Exactech, Inc. (2007) Summary page 1.

## Most influential descendants
- K173583: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (2018), 3 descendants of its own
- K182502: Alteon Acetabular Cup System (2019), 2 descendants of its own
- K210614: BENCOX Mirabo Z Cup Cortinium (2022), 1 descendant of its own
- K223223: BENCOX Mirabo Z Cup Cortinium (2023), 0 descendants of its own
- K141960: Exactech® Novation® Crown Cup® (2015), 0 descendants of its own

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1731-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- Jun 29, 2021 · Class II · Z-2121-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- Jun 29, 2021 · Class II · Z-2131-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- Jun 29, 2021 · Class II · Z-2130-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- Jun 29, 2021 · Class II · Z-2115-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- Jun 29, 2021 · Class II · Z-2125-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- Jun 29, 2021 · Class II · Z-2120-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

## 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. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon. * Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K100269
Methodology: https://510kreport.com/methodology