510(k) · Cleared
Recalled · Class II · 2018Zimmer M/L Taper Hip Prosthesis
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 May 12, 2006 as substantially equivalent to K032726 (Zimmer, Inc., 2003) and 3 other predicates after a 126-day review. Its family tree reaches back 6 generations to 1985. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 12, 2006
- Review
- 126 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K850055 (1985). 22 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 5 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 4 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 3 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 2 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 1 generation backK042337 Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004
- This deviceK060040 Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK192660 Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −5 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −4 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −3 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −2 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −1 | K042337 | Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 2004 | — |
| 0 (this device) | K060040 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | 2006 | — |
| +1 | K192660 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | 2020 | — |
| +2 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +3 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2025 | 1 | 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 24.3 · 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 |
|---|---|---|---|
| * | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 SeriesSummary page 1…nented prosthesis 21 CFR § 888.3353, product codes MER, LZO Predicate Devices: Zimmer®tM/L Taper Hip Prosthesis, K032726, cleared October 22, 2003 Zimmer M/L Taper Hip Prosthe… | 2003 |
| * | K042337 | Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingSummary page 1…cleared October 22, 2003 Zimmer M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, K042337, cleared November 4, 2004 Zimmner CPT® 12/14, K030265,… | 2004 |
| * | K030265 | CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Summary page 1…Ceramic Coating, K042337, cleared November 4, 2004 Zimmner CPT® 12/14, K030265, cleared March 4, 2003 Zimmner VerSys® Beaded Mid-Coat… | 2003 |
| * | K973714 | Versys Hip System Beaded Hip ProsthesisSummary page 1…eared March 4, 2003 Zimmner VerSys® Beaded Mid-Coat Stem, K9737 14, cleared December 24, 1997 Device Description: The Zimnmer M/L Taper Hip Prostheses are flat,… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192660 | Zimmer M/L Taper Hip Prosthesis | 2020 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2018 | Class II | Z-2361-2018 | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant.… |
| Mar 1, 2018 | Class II | Z-1192-2018 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 11 of the 21 ancestors have a recall of any class.
- Of its descendants, K192660 (Zimmer, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K032726.
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/K060040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060040: Zimmer M/L Taper Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060040
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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