# K093561: Zimmer Trabecular Metal Modular Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 28, 2010 after 161 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P960047 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021891: Zimmer Trabecular Metal Modular Acetabular System, Zimmer, Inc. (2002) Summary page 2.
- K071718: Trilogy Longevity Constrained Liner, Zimmer, Inc. (2007) Summary page 2.

## Indications for use
The TrabecularMetal Modular Acetabular System when used with a Trilogy®Neutral, Elevated, Offset or Oblique Liner is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NtDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant- The Trabecular Metal Modular Acetabular System when used with a Trilogy Longevity®) Constrained Liner is indicated for primary or revision total hip arthorplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. This device is intended for either cemented or noncemented use.

Source page: https://510kreport.com/device/K093561
Methodology: https://510kreport.com/methodology