510(k) · Cleared
Recalled · Class II · 2021Corin Trinity Acetabular System Ecima Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Cleared on Feb 6, 2012 as substantially equivalent to K110087 (Corin USA, 2011) after a 255-day review. Its family tree reaches back 11 generations to 1981. 33 later devices descend from it. It has been recalled once.
- Decided
- Feb 6, 2012
- Review
- 255 days
- Class
- Class II
- Product code
- OQI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K810258 (1981). 96 ancestors in all. 33 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 1 generation backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- This deviceK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012
- Descendant · cites it directly · 10 of its ownK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- Descendant · cites it directly · 8 of its ownK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- Descendant · 2 generations on · 5 of its ownK190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019
- Descendant · cites it directly · 4 of its ownK142761 Corin TaperFit Hip StemCorin USA · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 4 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 1 generation backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- This deviceK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · cites it directly10descendants
- K152893Corin Optimized Positioning System (OPS)Corin USA · 2016 · cites it directly8descendants
- K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA · 2019 · 2 generations on5descendants
- K142761Corin TaperFit Hip StemCorin USA · 2015 · cites it directly4descendants
- K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −4 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −3 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −2 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −1 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| 0 (this device) | K111481 | Corin Trinity Acetabular System Ecima Liners | Corin USA | 2012 | — |
| +1 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| +1 | K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016 | — |
| +2 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | 2019 | — |
| +1 | K142761 | Corin TaperFit Hip Stem | Corin USA | 2015 | 1 |
| +3 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 11 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 11 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 OQI? 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 OQI device
- #1 K252451 EPORE® XO cup systemscore 15.1 · 14 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K110087 | Corin Trinity Acetbular System with Hxlpe LinersSummary page 1…esis (21 CFR 888.3353) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: * Cohin Trinity Acetabular System with HXLPE Acetabular Liners (K110087) 9. Device Description: The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, tita… | 2011 |
What descends from it? (33)
See all 338 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170359 | Trinity™ Dual Mobility System | 2017 | 10 |
| K152893 | Corin Optimized Positioning System (OPS) | 2016 | 8 |
| K142761 | Corin TaperFit Hip Stem | 2015 | 4 |
| K180973 | Libertas Hip Replacement System | 2018 | 3 |
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | 2018 | 3 |
| K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… | 2021 | 2 |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | 2018 | 2 |
| K123692 | Pipeline Knee System | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2021 | Class II | Z-2606-2021 | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 95 ancestors have a recall of any class.
- Of its descendants, K170359 (Corin U.S.A. Limited, 2017) has gone furthest, with 10 descendants of its own.
- 15 other devices also cite its predicate K110087.
How does its category compare?
All OQI devicesOQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OQI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OQI
Too few OQI 510(k)s in any year since 2007 to give a median.
Recalls per year · OQI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQI
45in 2025
MAUDE reports naming product code OQI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 0 | — | 1 | 23 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
o Non-inflammatory degenerative joint disease including osteoarthritis and avascular
necrosis
o Rheumatoid arthritis
o Correction of functional deformity
o Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Trinity Acetabular System is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111481: Corin Trinity Acetabular System Ecima Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111481
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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