510(k) · Cleared
Recalled · Class II · 2016Trilogy Acetabular System
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 Apr 29, 1994 after a 206-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 391 later devices descend from it. It has been recalled 16 times.
- Decided
- Apr 29, 1994
- Review
- 206 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 16
- Predicates
- 0
391 later devices descend from it, 12 citing it directly.
- This deviceK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994
- Descendant · cites it directly · 248 of its ownK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
- Descendant · cites it directly · 246 of its ownK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
- Descendant · cites it directly · 192 of its ownK990135 Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999
- Descendant · cites it directly · 161 of its ownK993082 Exactech Acumatch Integrated Hip System a-Series Porous Coated…Exactech, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
Showing 5 of 391 descendants. See all descendants
Descendants cleared per year
1999high 38 (2025) · low 0 (2000)2026
Most influential descendants
Showing 5 of 391 · See all- K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · cites it directly248descendants
- K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc. · 2009 · cites it directly246descendants
- K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc. · 1999 · cites it directly192descendants
- K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc. · 1999 · cites it directly161descendants
- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 2 generations on145descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934765 | Trilogy Acetabular System | Zimmer, Inc. | 1994 | — |
| +1 | K021891 | Zimmer Trabecular Metal Modular Acetabular System | Zimmer, Inc. | 2002 | 3 |
| +1 | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | Zimmer, Inc. | 2009 | 3 |
| +1 | K990135 | Trilogy Acetabular System Longevity Crosslinked Polyethylene | Zimmer, Inc. | 1999 | — |
| +1 | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… | Exactech, Inc. | 1999 | 2 |
| +2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 12 | 0 |
| 2011 | 9 | 0 |
| 2012 | 25 | 0 |
| 2013 | 21 | 0 |
| 2014 | 16 | 0 |
| 2015 | 15 | 0 |
| 2016 | 15 | 0 |
| 2017 | 16 | 0 |
| 2018 | 23 | 0 |
| 2019 | 33 | 0 |
| 2020 | 26 | 0 |
| 2021 | 21 | 0 |
| 2022 | 25 | 0 |
| 2023 | 24 | 0 |
| 2024 | 26 | 0 |
| 2025 | 38 | 0 |
| 2026 | 27 | 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? (391)
See all 39112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021891 | Zimmer Trabecular Metal Modular Acetabular System | 2002 | 248 |
| K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | 2009 | 246 |
| K990135 | Trilogy Acetabular System Longevity Crosslinked Polyethylene | 1999 | 192 |
| K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component | 1999 | 161 |
| K030153 | Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32 | 2003 | 17 |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | 2017 | 16 |
| K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 | 12 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | 2024 | 2 |
| K213842 | ONVOY Acetabular System | 2022 | 1 |
| K092443 | Interface Acetabular Cup Liners | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2016 | Class II | Z-1684-2016 | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. |
| Jan 11, 2016 | Class II | Z-1145-2016 | 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. |
| Jan 11, 2016 | Class II | Z-1123-2016 | 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. |
| Jan 11, 2016 | Class II | Z-1161-2016 | 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. |
| Jan 11, 2016 | Class II | Z-1115-2016 | 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. |
| Dec 4, 2014 | Class II | Z-0875-2015 | Under Investigation by firm | Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but… |
| Nov 21, 2014 | Class II | Z-0824-2015 | Equipment maintenance | Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. . |
| Jun 12, 2014 | Class II | Z-2032-2014 | Process design | Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags… |
| 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… |
| Sep 14, 2012 | Class II | Z-0771-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| Sep 14, 2012 | Class II | Z-0773-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| Sep 14, 2012 | Class II | Z-0769-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| Sep 14, 2012 | Class II | Z-0775-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| Sep 14, 2012 | Class II | Z-0772-2013 | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of… |
| Oct 19, 2007 | Not classified | Z-0620-2008 | Process control | Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim. |
| Jun 26, 2006 | Not classified | Z-1344-06 | Other | Lack of assurance of sterility, as the sterile barrier packaging may have been compromised. |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021891 (Zimmer, Inc., 2002) has gone furthest, with 248 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
2007high 25 (2012) · low 3 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
2007high 410 (2021) · low 76 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
2007high 30 (2012) · low 1 (2008)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
2007high 7,130 (2019) · low 509 (2007)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/K934765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934765: Trilogy Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934765
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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