510(k) · Cleared
Recalled · Class II · 2016Trilogy Acetabular Shell & Liners 36MM
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 20, 1995 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 214 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 20, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 0
214 later devices descend from it, 4 citing it directly.
- This deviceK953490 Trilogy Acetabular Shell & Liners 36MMZimmer, Inc. · 1995
- Descendant · cites it directly · 192 of its ownK990135 Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999
- Descendant · 2 generations on · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
- Descendant · 2 generations on · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- Descendant · 3 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
Showing 5 of 214 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 214 · See all- K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999 · cites it directly192descendants
- K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · 2 generations on137descendants
- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 2 generations on88descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 3 generations on59descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 3 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953490 | Trilogy Acetabular Shell & Liners 36MM | Zimmer, Inc. | 1995 | — |
| +1 | K990135 | Trilogy Acetabular System Longevity Crosslinked Polyethylene | Zimmer, Inc. | 1999 | — |
| +2 | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT… | Zimmer, Inc. | 2011 | — |
| +2 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| +3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +3 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 14 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 14 | 0 |
| 2019 | 22 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 16 | 0 |
| 2023 | 12 | 0 |
| 2024 | 21 | 0 |
| 2025 | 21 | 0 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (214)
See all 2144 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 |
|---|---|---|---|---|
| Jan 11, 2016 | Class II | Z-1160-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Oct 11, 2013 | Class II | Z-1024-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990135 (Zimmer, Inc., 1999) has gone furthest, with 192 descendants of its own.
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 | — |
https://510kreport.com/device/K953490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953490: Trilogy Acetabular Shell & Liners 36MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953490
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026