# K072121: Trabecular Metal Acetabular Revision System Cemented Contrained Liner

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 7, 2008 after 159 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983128 (1998). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 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)

## Cited in the summary but kept off the family tree
- K071717: GE Oec Altitude, Shimadzu Corp. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K181366: REDAPT Porous Acetabular Shell (2018), 1 descendant of its own
- K243571: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (2025), 0 descendants of its own
- K242744: Trinity EVO Acetabular Shell (2025), 0 descendants of its own

## Indications for use
The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented to a TMARS 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 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/K072121
Methodology: https://510kreport.com/methodology