# K071676: Exactech Novation Crown Cup Constrained Liners and Rings

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jul 19, 2007 after 30 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- 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: 4 generations back to P960047 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040601: Exactech Acumatch a-Series & MCS Constrained Acetabular Liners, Exactech, Inc. (2004) Summary page 1.

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0581-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Aug 11, 2022 · Class II · Z-1730-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

## Indications for use
Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation ® 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 are compatible with Exactech press-fit or cemented femoral stem components.

Source page: https://510kreport.com/device/K071676
Methodology: https://510kreport.com/methodology