510(k) · Cleared
Recalled · Class II · 2021Trinity Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Nov 23, 2010 as substantially equivalent to K001534 (DePuy Orthopaedics, Inc., 2000) and 5 other predicates after a 382-day review. Its family tree reaches back 6 generations to 1996. 117 later devices descend from it. It has been recalled once.
- Decided
- Nov 23, 2010
- Review
- 382 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K955033 (1996). 48 ancestors in all, the oldest K840643 (1984). 117 later devices descend from it, 19 citing it directly.
- Root · 6 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 4 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 3 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 2 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 1 generation backK043079 Bicontact Hip System with U-CapAesculap · 2004
- This deviceK093472 Trinity Acetabular SystemCorin USA · 2010
- Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · 2 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · 3 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 4 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 5 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 2 generations on62descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 3 generations on61descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 4 generations on48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 5 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −5 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −4 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −3 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −2 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −1 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| 0 (this device) | K093472 | Trinity Acetabular System | Corin USA | 2010 | — |
| +1 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +2 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +3 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +4 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +5 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
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 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 10 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K001534 | Pinnacle Acetabular System | 2000 |
| * | K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…Summary page 1…ally Marketed Devices to which Substantial Equivalence is claimed: a. Depuy Pinnacle Acetabular System (K(001 534) b. Depuy Duraloc Option Acetabular Cup System (K(040544) c. Aesculap BiContact Hip System with li-Cap® (1(043079) d. Corin Zyranox Zirconia Ceramic Femoral Heads (K(992235) e.… | 2004 |
| * | K043079 | Bicontact Hip System with U-CapSummary page 1…aimed: a. Depuy Pinnacle Acetabular System (K(001 534) b. Depuy Duraloc Option Acetabular Cup System (K(040544) c. Aesculap BiContact Hip System with li-Cap® (1(043079) d. Corin Zyranox Zirconia Ceramic Femoral Heads (K(992235) e. Corin Taper-Fit Total.Hip System (1(003666) E Apex Modula… | 2004 |
| * | K992235 | Zyranox Zirconia Ceramic Femoral HeadsSummary page 1…. Depuy Duraloc Option Acetabular Cup System (K(040544) c. Aesculap BiContact Hip System with li-Cap® (1(043079) d. Corin Zyranox Zirconia Ceramic Femoral Heads (K(992235) e. Corin Taper-Fit Total.Hip System (1(003666) E Apex Modular Acetabular Cup (1031110) 8. Device Description: The '… | 1999 |
| * | K003666 | Taper-Fit Total Hip SystemSummary page 1…0544) c. Aesculap BiContact Hip System with li-Cap® (1(043079) d. Corin Zyranox Zirconia Ceramic Femoral Heads (K(992235) e. Corin Taper-Fit Total.Hip System (1(003666) E Apex Modular Acetabular Cup (1031110) 8. Device Description: The 'Trinity Acetabular System is a modular acetabular… | 2001 |
| * | K031110 | Apex Modular Acetabular CupSummary page 1…ith li-Cap® (1(043079) d. Corin Zyranox Zirconia Ceramic Femoral Heads (K(992235) e. Corin Taper-Fit Total.Hip System (1(003666) E Apex Modular Acetabular Cup (1031110) 8. Device Description: The 'Trinity Acetabular System is a modular acetabular cup system consisting of a press fit,… | 2003 |
What descends from it? (117)
See all 11719 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110087 | Corin Trinity Acetbular System with Hxlpe Liners | 2011 | 109 |
| K130343 | Corin Trinity Acetabular System with Extra-Long Heads | 2013 | 33 |
| K122305 | Corin Trinity-I Acetabular Shell | 2012 | 28 |
| K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | 2013 | 23 |
| K131647 | Trinity Acetabular System | 2013 | 22 |
| K130128 | Trinity Acetabular System | 2013 | 17 |
| K121563 | Corin Trifit TS Hip | 2012 | 10 |
| K182321 | MobileLink Acetabular Cup System | 2019 | 8 |
| K152893 | Corin Optimized Positioning System (OPS) | 2016 | 8 |
| K103518 | Trinity Acetabular System | 2011 | 8 |
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-2604-2021 | 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 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 12 of the 47 ancestors have a recall of any class.
- Of its descendants, K110087 (Corin USA, 2011) has gone furthest, with 109 descendants of its own.
- 14 other devices also cite its predicate K001534.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Developmental dysplasia of the hip (DDH) and 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/K093472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093472: Trinity Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093472
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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