# K021891: Zimmer Trabecular Metal Modular Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 5, 2002 after 90 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934765 (1994). 2 ancestors in all.
248 later devices descend from it; 4 cite it directly.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 1.
- K001039: The Implex Hedrocel Modular Elliptical Acetabular Cup, Implex Corp. (2000)

## Most influential descendants
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System (2009), 246 descendants of its own
- K093846: Longevity IT Highly Crosslinked Polyethylene Elevated Liners (2010), 144 descendants of its own
- K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper (2010), 143 descendants of its own
- K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI (2011), 137 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own

## Recalls of this device
- Apr 1, 2014 · Class II · Z-1496-2014: The shell was missing the locking ring.
- Sep 1, 2011 · Not classified · Z-3279-2011: Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may 
- Aug 18, 2010 · Not classified · Z-0060-2011: The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.

## Indications for use
This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. This device is intended for either cemented or noncemented use.

Source page: https://510kreport.com/device/K021891
Methodology: https://510kreport.com/methodology