# K040613: Exactech Acumatch a-Series and MCS Acetabular Shells and Liners

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jun 4, 2004 after 87 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921114 (1993). 6 ancestors in all.
61 later devices descend from it; 1 cites it directly.
0 of 68 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 2.
- K000242: Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum Acetabular Component with Hydroxyapatite, Exactech, Inc. (2000) Summary page 2.
- K921114: Exactech MCS Porous Coated Total Hip Acetabular, Exactech, Inc. (1993) Summary page 2.
- K990197: Modulus Compatible Stability (MCS)-HA Total Hip System, Exactech, Inc. (1999) Summary page 2.

## Most influential descendants
- K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene (2005), 60 descendants of its own
- 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

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1726-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

## 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.

Source page: https://510kreport.com/device/K040613
Methodology: https://510kreport.com/methodology