510(k) · Cleared
Recalled · Class II · 2017ZMR Hip System-XL, Models 9921, 9922 and 9923
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 Jun 24, 2003 as substantially equivalent to K992667 (Zimmer, Inc., 1999) and 1 other predicate after a 35-day review. Its family tree reaches back 4 generations to 1985. 28 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 24, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 4 generations to K850055 (1985). 9 ancestors in all. 28 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 3 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 2 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 1 generation backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- This deviceK031572 ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc. · 2003
- Descendant · cites it directly · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · cites it directly · 7 of its ownK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- Descendant · 3 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · cites it directly27descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 2 generations on13descendants
- K151739Revision Femoral StemLima Corporate S.P.A. · 2015 · cites it directly7descendants
- K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · 2 generations on5descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −3 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −2 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −1 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| 0 (this device) | K031572 | ZMR Hip System-XL, Models 9921, 9922 and 9923 | Zimmer, Inc. | 2003 | — |
| +1 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| +2 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +1 | K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015 | — |
| +2 | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
| +3 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
Planning a device in LPH? 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? (2)
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 |
|---|---|---|---|
| * | K992667 | ZMR Hip System-Revision TaperSummary page 1…al/polymer/metal semiconstrained porous coated uncemented prosthesis, 21 CFR 888.3358 Predicate Devices: ZMR® Hip System-Revision Taper, manufactured by Zimmer, Inc., K992667, cleared October 27, 1999 ZMR® Hip System-Porous Revision, manufactured by Zimmer, Inc., K994286, cleared March 10, 2000 Device… | 1999 |
| * | K994286 | ZMR Hip System-Porous RevisionSummary page 1…Devices: ZMR® Hip System-Revision Taper, manufactured by Zimmer, Inc., K992667, cleared October 27, 1999 ZMR® Hip System-Porous Revision, manufactured by Zimmer, Inc., K994286, cleared March 10, 2000 Device Description: ' Like its predicates, the ZMR® Hip System-XL prosthesis is a modular femoral stem m… | 2000 |
What descends from it? (28)
See all 283 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2017 | Class II | Z-2583-2017 | Packaging | 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 | Packaging | 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 | 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K092331 (Encore Medical L.P., 2010) has gone furthest, with 27 descendants of its own.
- 6 other devices also cite its predicate K992667.
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/K031572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031572: ZMR Hip System-XL, Models 9921, 9922 and 9923.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031572
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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