510(k) · Cleared
Recalled · Class II · 2018Zimmer M/L Taper Hip Prosthesis, 7711 Series
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 22, 2003 as substantially equivalent to K921301 (Biomet, Inc., 1994) and 3 other predicates after a 49-day review. Its family tree reaches back 4 generations to 1985. 1 of the 99 devices in its family, counting itself, has a Class I recall. 84 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 22, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 4 generations to K850055 (1985). 14 ancestors in all. 84 later devices descend from it, 7 citing it directly. 1 of the 99 devices in this family, counting this one, has a Class I recall.
- 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 deviceK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003
- Descendant · cites it directly · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 2 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · 2 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- Descendant · 2 generations on · 19 of its ownK130899 Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013
- Descendant · 3 generations on · 14 of its ownK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…2 generations on · 2007
Most influential descendants
Showing 5 of 84 · See all- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · cites it directly73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 2 generations on41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 2 generations on34descendants
- K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013 · 2 generations on19descendants
- K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012 · 3 generations on14descendants
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) | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | — |
| +1 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +2 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +2 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| +2 | K130899 | Biolox Delta Ceramic Femoral Heads | Zimmer GmbH | 2013 | — |
| +3 | K120030 | Taperloc Complete Size 4MM and XR 123 | Biomet Manufacturing Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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? (4)
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 |
|---|---|---|---|
| * | K921301 | Taperloc Femoral Stem and Universal Acetabular ComSummary page 1…porous coated uncemented prosthesis Reference and Product Code: 21 CFR 4 888.3358, LPH Predicate Device: I . Biomet Taperloc, K92 1301, cleared 2- 16-94; and K020963, cleared 4- 16-02… | 1994 |
| * | K020963 | Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral StemSummary page 1…21 CFR 4 888.3358, LPH Predicate Device: I . Biomet Taperloc, K92 1301, cleared 2- 16-94; and K020963, cleared 4- 16-02 2. Zimmer ZMRB Hip System Porous Revision,… | 2002 |
| * | K994286 | ZMR Hip System-Porous RevisionSummary page 1…K020963, cleared 4- 16-02 2. Zimmer ZMRB Hip System Porous Revision, K994286, cleared 3- 10-00 3. Zimmer Ver$\.s@ Hip System Fiber Metal Taper… | 2000 |
| * | K964769 | Versys Hip System--Fiber Metal Taper Hip ProsthesisSummary page 1…ared 3- 10-00 3. Zimmer Ver$\.s@ Hip System Fiber Metal Taper Hip Prosthesis, K964769, cleared 3- 13-97 Device Description: The Zinime& M/L Taper Hip Prosthesis is a… | 1997 |
What descends from it? (84)
See all 847 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071723 | Zimmer Porolock Mis Stem | 2008 | 73 |
| K042337 | Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating | 2004 | 11 |
| K163577 | Ecofit® Hip System | 2017 | 9 |
| K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology | 2007 | 5 |
| K060040 | Zimmer M/L Taper Hip Prosthesis | 2006 | 3 |
| K192660 | Zimmer M/L Taper Hip Prosthesis | 2020 | 2 |
| K161830 | Zimmer M/L Taper Hip Prosthesis | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2018 | Class II | Z-1191-2018 | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. |
| Feb 11, 2016 | Class II | Z-1046-2016 | Under Investigation by firm | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD… |
| May 23, 2014 | Class II | Z-2033-2014 | Packaging | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. |
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 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 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 3.6 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K071723 (Zimmer GmbH, 2008) has gone furthest, with 73 descendants of its own.
- 13 other devices also cite its predicate K921301.
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?
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected…
Read the full statement (133 words)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032726: Zimmer M/L Taper Hip Prosthesis, 7711 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032726
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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