# K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Sep 6, 2005 after 85 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931641 (1994). 19 ancestors in all.
60 later devices descend from it; 2 cite it directly.
0 of 80 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 3.
- K040613: Exactech Acumatch a-Series and MCS Acetabular Shells and Liners, Exactech, Inc. (2004) Summary page 3.
- K041906: Exactech 12/14 Total Hip System, Exactech, Inc. (2004) Summary page 3.

## Most influential descendants
- K070479: Exactech Novation Crown Cup and Liners (2007), 59 descendants of its own
- K102975: Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole (2010), 53 descendants of its own
- K122798: Integrip Acetabular Shell, Integrip Revision Acetabular Shell (2012), 36 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K112898: Delta TT Cups, Delta TT Liners, Bone Screws (2012), 12 descendants of its own

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1728-2022: 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-2122-2021: 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-2117-2021: 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-2118-2021: 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-2112-2021: 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-2113-2021: 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-2116-2021: 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-2124-2021: 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-2133-2021: 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-2114-2021: 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
AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

Source page: https://510kreport.com/device/K051556
Methodology: https://510kreport.com/methodology