510(k) · Cleared
Recalled · 2011ZMR Hip System-Porous Revision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 10, 2000 as substantially equivalent to K921274 (Biomet, Inc., 1994) and 2 other predicates after an 81-day review. Its family tree reaches back 3 generations to 1985. 1 of the 114 devices in its family, counting itself, has a Class I recall. 105 later devices descend from it. It has been recalled 11 times.
- Decided
- Mar 10, 2000
- Review
- 81 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 3 generations to K850055 (1985). 8 ancestors in all. 105 later devices descend from it, 4 citing it directly. 1 of the 114 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 2 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 1 generation backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- This deviceK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000
- Descendant · cites it directly · 84 of its ownK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 3 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · 3 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- Descendant · cites it directly · 28 of its ownK031572 ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc. · 2003 · Recalled
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…3 generations on · 2007
Most influential descendants
Showing 5 of 105 · See all- K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · cites it directly84descendants
- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 2 generations on73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 3 generations on41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 3 generations on34descendants
- K031572ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc. · 2003 · cites it directly28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −2 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −1 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| 0 (this device) | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | — |
| +1 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| +2 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +3 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +3 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| +1 | K031572 | ZMR Hip System-XL, Models 9921, 9922 and 9923 | Zimmer, Inc. | 2003 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 6 | 0 |
| 2019 | 11 | 0 |
| 2020 | 9 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921274 | Metallic Toatal Hip SystemSummary page 1…is . Classification Name: Hip joint metal/polymer semiconstrained uncemented prosthesis . Predicate Devices: . Impac™ Modular Total Hip System, manufactured by Biomet, K921274, cleared February 15, 1994 . Coated ZT™ Proximal Sleeve of the S-ROM™ Total Hip System, manufactured by Johnson & Johnson (previ… | 1994 |
| * | K934412 | Coated ZT Proximal SleeveSummary page 1…leared February 15, 1994 . Coated ZT™ Proximal Sleeve of the S-ROM™ Total Hip System, manufactured by Johnson & Johnson (previously Joint Medical Products Corporation), K934412, cleared June 3, 1994 . Mallory-Head Modular Porous Series, manufactured by Biomet, K921274, cleared February 15, 1994 256 % A… | 1994 |
| * | K992667 | ZMR Hip System-Revision TaperSummary page 2…ristol-Myers Squibl Company /95056 Summary of Safety and Effectiveness 2y Pof 7 (Continued) / . ZMR™ Hip System-Revision Taper, manufactured by Zimmer, K992667, cleared October 27, 1999 . Device Description The ZMR Porous Revision Hip Prosthesis is a femoral stem manufactured from Tivan… | 1999 |
What descends from it? (105)
See all 1054 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2011 | Not classified | Z-0367-2012 | Nonconforming Material/Component | 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 during normal production and had not been… |
| Nov 16, 2011 | Not classified | Z-0368-2012 | Nonconforming Material/Component | 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 during normal production and had not been… |
| Oct 21, 2011 | Not classified | Z-0321-2012 | Error in labeling | 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 | Error in labeling | 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 | Error in labeling | 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 | Error in labeling | 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 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1478-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1477-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1480-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1479-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
The 5 latest of 11 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K032726 (Zimmer, Inc., 2003) has gone furthest, with 84 descendants of its own.
- 4 other devices also cite its predicate K921274.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994286: ZMR Hip System-Porous Revision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994286
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026