510(k) Report

510(k) · Cleared

Cleared

Trinity PLUS Acetabular Shell

K172551510(k) TraditionalCleared Jun 15, 2018296-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corin U.S.A. Limited · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 15, 2018 as substantially equivalent to K093472 (Corin USA, 2010) and 4 other predicates after a 296-day review. Its family tree reaches back 13 generations to 1981. 4 later devices descend from it.

Decided
Jun 15, 2018
Review
296 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
5

Its longest line of descent runs back 13 generations to K810258 (1981). 166 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2010: 5 other ancestors2012: 2 other ancestors2009: 5 other ancestors2004: 8 other ancestors2003: 7 other ancestors2001: 8 other ancestors2000: 16 other ancestors1999: 10 other ancestors2011: 1 other ancestor2007: 5 other ancestors2005: 6 other ancestors2002: 9 other ancestors1997: 9 other ancestors1996: 11 other ancestors1994: 19 other ancestors1991: 3 other ancestors2006: 1 other ancestor1998: 4 other ancestors1983: 1 other ancestor1995: 8 other ancestors1993: 4 other ancestors1992: 2 other ancestors1990: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors1984: 1 other ancestor1987: 1 other ancestor2021: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010×2: 2 generations cleared close together, K103120 (2011), K110087 (2011) ×2: 2 generations cleared close together, K122305 (2012), K130128 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 13 other ancestors3 generations back: 23 other ancestors4 generations back: 29 other ancestors5 generations back: 39 other ancestors6 generations back: 27 other ancestors7 generations back: 15 other ancestors8 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K130128 · Trinity Acetabular System · Corin Medical · 2013K122305 · Corin Trinity-I Acetabular Shell · Corin USA · 2012K110087 · Corin Trinity Acetbular System with Hxlpe Liners · Corin USA · 2011K103120 · Corin Biolox Delta Femoral Heads · Corin USA · 2011K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations between
  3. 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  4. 2 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
  5. 1 generation backK130128 Trinity Acetabular SystemCorin Medical · 2013
  6. This deviceK172551 Trinity PLUS Acetabular ShellCorin U.S.A. Limited · 2018
  7. Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
  8. Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
  9. Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
  10. Descendant · cites it directly · 0 of its ownK242744 Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025
Show all 13 generations
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
  11. 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  12. 2 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
  13. 1 generation backK130128 Trinity Acetabular SystemCorin Medical · 2013
  14. This deviceK172551 Trinity PLUS Acetabular ShellCorin U.S.A. Limited · 2018

Most influential descendants

Showing 4 of 4 · See all
  • K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · cites it directly2descendants
  • K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 2 generations on1descendant
  • K261576Icona Hip StemCorin, Ltd. · 2026 · 3 generations on0descendants
  • K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−12K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−11K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−10K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−9K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−8K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−7K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−6K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−4K103120Corin Biolox Delta Femoral HeadsCorin USA2011—
−3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
−2K122305Corin Trinity-I Acetabular ShellCorin USA2012—
−1K130128Trinity Acetabular SystemCorin Medical2013—
0 (this device)K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited2018—
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular…Corin, Ltd.2021—
+2K241472Icona Hip StemCorin U.S.A. Limited2024—
+3K261576Icona Hip StemCorin, Ltd.2026—
+1K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198410
198520
198620
198710
199010
199130
199220
199340
1994190
199580
1996110
199790
199840
1999100
2000160
200180
200290
200370
200480
200560
200610
200750
200950
201050
201110
201220
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202410
202510
202610
FIG. 1 — Lineage of K172551, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K093472Trinity Acetabular System
Summary page 4
…uncemented prosthesis (21CFR 888.3358) 8. Legally Marketed Devices to which Substantial Equivalence is claimed:  Corin Trinity™ Acetabular System (K093472, K110087, K122305 and K130128) (Primary predicate)  Biomet G7 OsseoTi (K140669) 9. Device Description: The Tr…
Corin USA20101
*K110087Corin Trinity Acetbular System with Hxlpe Liners
Summary page 4
…uncemented prosthesis (21CFR 888.3358) 8. Legally Marketed Devices to which Substantial Equivalence is claimed:  Corin Trinity™ Acetabular System (K093472, K110087, K122305 and K130128) (Primary predicate)  Biomet G7 OsseoTi (K140669) 9. Device Description: The Trinity™ PL…
Corin USA2011—
*K122305Corin Trinity-I Acetabular Shell
Summary page 4
…nted prosthesis (21CFR 888.3358) 8. Legally Marketed Devices to which Substantial Equivalence is claimed:  Corin Trinity™ Acetabular System (K093472, K110087, K122305 and K130128) (Primary predicate)  Biomet G7 OsseoTi (K140669) 9. Device Description: The Trinity™ PLUS Acetab…
Corin USA2012—
*K130128Trinity Acetabular System
Summary page 4
…sis (21CFR 888.3358) 8. Legally Marketed Devices to which Substantial Equivalence is claimed:  Corin Trinity™ Acetabular System (K093472, K110087, K122305 and K130128) (Primary predicate)  Biomet G7 OsseoTi (K140669) 9. Device Description: The Trinity™ PLUS Acetabular Shell i…
Corin Medical2013—
*K140669G7 Osseoti Acetublar Shells
Summary page 4
…Substantial Equivalence is claimed:  Corin Trinity™ Acetabular System (K093472, K110087, K122305 and K130128) (Primary predicate)  Biomet G7 OsseoTi (K140669) 9. Device Description: The Trinity™ PLUS Acetabular Shell is a component of a modular acetabular cup system consistin…
Biomet, Inc.2014—

Also cleared against K093472: 18 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 37 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
  • 41 of the 165 ancestors have a recall of any class.
  • Of its descendants, K201657 (Corin, Ltd., 2021) has gone furthest, with 2 descendants of its own.
  • 18 other devices also cite its predicate K093472.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
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

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The indications for the Corin Trinity™ PLUS Acetabular Shell as a total hip arthroplasty include:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,

Rheumatoid arthritis,

Correction of functional deformity,

Revision of previously failed total hip arthroplasty

Developmental dysplasia of the hip (DDH),

The Trinity™ PLUS Acetabular Shell is indicated for cementless use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K172551: Trinity PLUS Acetabular Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172551

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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