# K243571: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet
- Decided: Jul 31, 2025 after 255 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983128 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051516: Trabecular Metal Revision Shell Liners, Zimmer, Inc. (2005) Summary page 5.
- K072121: Trabecular Metal Acetabular Revision System Cemented Contrained Liner, Zimmer, Inc. (2008) Summary page 5.

## Indications for use
Acetabular Liners: The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage. Constrained Liners: The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex 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 intraoperative instability and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K243571
Methodology: https://510kreport.com/methodology