510(k) · Cleared
Recalled · 2009ZMR Hip System-Revision Taper
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 Oct 27, 1999 as substantially equivalent to K921274 (Biomet, Inc., 1994) and 2 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1985. 1 of the 121 devices in its family, counting itself, has a Class I recall. 114 later devices descend from it. It has been recalled once.
- Decided
- Oct 27, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K850055 (1985). 6 ancestors in all. 114 later devices descend from it, 7 citing it directly. 1 of the 121 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 1 generation backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- This deviceK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999
- Descendant · cites it directly · 105 of its ownK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 84 of its ownK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 4 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · 4 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…4 generations on · 2007
Most influential descendants
Showing 5 of 114 · See all- K994286ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · cites it directly105descendants
- K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · 2 generations on84descendants
- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 3 generations on73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 4 generations on41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −1 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| 0 (this device) | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | — |
| +1 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| +2 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| +3 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +4 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +4 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2010 | 3 | 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 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 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 mctal/polymer semiconstrained uncemented prosthesis . Predicate Devices: - Impact Modular Total Hip System, manufactured by Biomet, K921274, cleared June 3, 1994 - MP Reconstruction Hip Stem, manufactured by Link, K955296, cleared February 14, 1996 - VerSys® Hip Syst… | 1994 |
| * | K955296 | Link MP Reconstruction HipSummary page 1…hesis . Predicate Devices: - Impact Modular Total Hip System, manufactured by Biomet, K921274, cleared June 3, 1994 - MP Reconstruction Hip Stem, manufactured by Link, K955296, cleared February 14, 1996 - VerSys® Hip System-Enhanced Taper Hip Prosthesis, manufactured by Zimmer, K961378, cleared October… | 1996 |
| * | K961378 | Delta Hip ProsthesisSummary page 1…1994 - MP Reconstruction Hip Stem, manufactured by Link, K955296, cleared February 14, 1996 - VerSys® Hip System-Enhanced Taper Hip Prosthesis, manufactured by Zimmer, K961378, cleared October 8, 1996 133 % A Bristol-Myers Squibb Company Summary of Safety and Effectiveness (Continued)… | 1996 |
What descends from it? (114)
See all 1147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994286 | ZMR Hip System-Porous Revision | 2000 | 105 |
| K031572 | ZMR Hip System-XL, Models 9921, 9922 and 9923 | 2003 | 28 |
| K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; | 2010 | 27 |
| K033893 | Spectrum Modular System | 2004 | 8 |
| K151739 | Revision Femoral Stem | 2015 | 7 |
| K113296 | ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer | 2012 | 2 |
| K102424 | Prevision Hip System with Recon Ring | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2009 | Not classified | Z-1615-2009 | Process control | The threads on the screw are incomplete/non-functional. |
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 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K994286 (Zimmer, Inc., 2000) has gone furthest, with 105 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/K992667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992667: ZMR Hip System-Revision Taper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992667
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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