# K994286: ZMR Hip System-Porous Revision

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 10, 2000 after 81 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850055 (1985). 8 ancestors in all.
105 later devices descend from it; 4 cite it directly.
1 of 114 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921274: Metallic Toatal Hip System, Biomet, Inc. (1994) Summary page 1.
- K934412: Coated ZT Proximal Sleeve, Joint Medical Products Corp. (1994) Summary page 1.
- K992667: ZMR Hip System-Revision Taper, Zimmer, Inc. (1999) Summary page 2.

## Most influential descendants
- K032726: Zimmer M/L Taper Hip Prosthesis, 7711 Series (2003), 84 descendants of its own
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K031572: ZMR Hip System-XL, Models 9921, 9922 and 9923 (2003), 28 descendants of its own

## Recalls of this device
- Nov 16, 2011 · Not classified · Z-0367-2012: Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off durin
- Nov 16, 2011 · Not classified · Z-0368-2012: Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off durin
- 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.
- Aug 2, 2006 · Not classified · Z-1476-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1478-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1477-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1480-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1479-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

## 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/K994286
Methodology: https://510kreport.com/methodology