# K040601: Exactech Acumatch a-Series & MCS Constrained Acetabular Liners

- Pathway: 510(k) (Abbreviated)
- Applicant: Exactech, Inc.
- Decided: Oct 4, 2004 after 210 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- 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: 3 generations back to P960047 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.
- K921114: Exactech MCS Porous Coated Total Hip Acetabular, Exactech, Inc. (1993) Summary page 3.
- K021728: Ringloc Constrained Liners II, Biomet, Inc. (2002) Summary page 3.
- K030923: Epsilon Durasul Constrained Acetabular Liner, Centerpulse Orthopedics, Inc. (2003) Summary page 3.

## Most influential descendants
- K071676: Exactech Novation Crown Cup Constrained Liners and Rings (2007), 0 descendants of its own

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1725-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

## Indications for use
Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners are compoients of the Exactech AcuMatch A-Series or MCS non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.

Source page: https://510kreport.com/device/K040601
Methodology: https://510kreport.com/methodology