# K061067: Trabecular Metal Acetabular Augments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular
- Decided: May 25, 2006 after 38 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001471 (2000). 3 ancestors in all.
79 later devices descend from it; 5 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042871: Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3, Zimmer Trabecular (2004) Summary page 2.
- K012507: The Trabecular Metal Technology Acetabular Augment System, Models 4893-XX-YY (Zimmer), 02-212-05XX1 ( Implex), Implex Corp. (2001) Summary page 2.
- K001471: The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ, Implex Corp. (2000) Summary page 2.

## Most influential descendants
- K100391: Depuy Universal Gription TF Cones (2010), 53 descendants of its own
- K143393: Triathlon Tritanium Cone Augments (2015), 40 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K102019: Restoration Acetabular Wedge Augments (2011), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own

## Recalls of this device
- Apr 6, 2010 · Not classified · Z-2214-2010: The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
- Apr 6, 2010 · Not classified · Z-2215-2010: The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
- Apr 6, 2010 · Not classified · Z-2216-2010: The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
- Apr 6, 2010 · Not classified · Z-2217-2010: The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.

## Indications for use
Trabecular Metal Acetabular Augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

Source page: https://510kreport.com/device/K061067
Methodology: https://510kreport.com/methodology