# K113296: ZMR Hip System  KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 14, 2012 after 311 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: 7 generations back to K921308 (1994). 87 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992667: ZMR Hip System-Revision Taper, Zimmer, Inc. (1999) Summary page 2.
- K994286: ZMR Hip System-Porous Revision, Zimmer, Inc. (2000) Summary page 2.
- K031572: ZMR Hip System-XL, Models 9921, 9922 and 9923, Zimmer, Inc. (2003) Summary page 2.
- K101086: Taperloc Complete, Biomet, Inc. (2010) Summary page 2.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) Summary page 2.
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;, Encore Medical L.P. (2010) Summary page 2.
- K061067: Trabecular Metal Acetabular Augments, Zimmer Trabecular (2006) Summary page 2.
- K042871: Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3, Zimmer Trabecular (2004) Summary page 2.
- K962468: Hedrocel Acetabular Restrictor, Implex Corp. (1997) Summary page 2.
- K061226: Trabecular Metal Acetabular Revision System Cage, Zimmer, Inc. (2006) Summary page 2.

## Most influential descendants
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own

## Indications for use
The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

Source page: https://510kreport.com/device/K113296
Methodology: https://510kreport.com/methodology