# K031572: ZMR Hip System-XL, Models 9921, 9922 and 9923

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Jun 24, 2003 after 35 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K850055 (1985). 9 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 38 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 1.
- K994286: ZMR Hip System-Porous Revision, Zimmer, Inc. (2000) Summary page 1.

## Most influential descendants
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; (2010), 27 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K151739: Revision Femoral Stem (2015), 7 descendants of its own
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own

## Recalls of this device
- Feb 28, 2017 · Class II · Z-2583-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2582-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Oct 21, 2011 · Not classified · Z-0321-2012: This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.
- Oct 21, 2011 · Not classified · Z-0323-2012: This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.
- Oct 21, 2011 · Not classified · Z-0324-2012: This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.
- Oct 21, 2011 · Not classified · Z-0322-2012: This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.

## 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/K031572
Methodology: https://510kreport.com/methodology