# K061226: Trabecular Metal Acetabular Revision System Cage

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 2, 2006 after 92 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: 2 generations back to K953578 (1995). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960678: Burch/Schneider Reinforcement Cage, Intermedics Orthopedics (1996) Summary page 1.

## Most influential descendants
- K113296: ZMR Hip System  KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (2012), 2 descendants of its own
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K253630: Mpact 3D Metal Foam (2026), 0 descendants of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own

## Indications for use
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof: reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis.joint reconstruction. arthrodesis. herni-arthroplasty. or total hip replacement.

Source page: https://510kreport.com/device/K061226
Methodology: https://510kreport.com/methodology