510(k) · Cleared

Cleared

Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads

K201657510(k) TraditionalCleared Jul 28, 2021405-day reviewClass II21 CFR 888.3353

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

Corin, Ltd. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 28, 2021 as substantially equivalent to K093472 (Corin USA, 2010) and 35 other predicates after a 405-day review. Its family tree reaches back 16 generations to 1981. 1 of the 400 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Jul 28, 2021
Review: 405 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 36

Its longest line of descent runs back 16 generations to K810258 (1981). 398 ancestors in all, the oldest K800207 (1980). 2 later devices descend from it, 1 citing it directly. 1 of the 400 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
12 generations between
3 generations backK121563 Corin Trifit TS HipCorin USA · 2012 · Recalled
2 generations backK153772 Corin TriFit TS HipCorin U.S.A. Limited · 2016
1 generation backK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
This deviceK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
Descendant · cites it directly · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
Descendant · 2 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026

Show all 16 generations

Root · 16 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
15 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
14 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
13 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
12 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
11 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
10 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
9 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
8 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
7 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
6 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
5 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
4 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
3 generations backK121563 Corin Trifit TS HipCorin USA · 2012 · Recalled
2 generations backK153772 Corin TriFit TS HipCorin U.S.A. Limited · 2016
1 generation backK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
This deviceK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021

Class I recalls in this family

K091423 Profemur Hip System Modular Necks3 generations back · 2009

Most influential descendants

Showing 2 of 2 · See all

K241472Icona Hip StemCorin U.S.A. Limited · 2024 · cites it directly1descendant
K261576Icona Hip StemCorin, Ltd. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−16	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−15	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−14	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
−13	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
−12	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
−11	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
−10	K071535	Biolox Delta Ceramic Femoral Head	Zimmer, Inc.	2007	3
−9	K082844	Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…	Encore Medical L.P.	2008	1
−8	K100412	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	2010	—
−7	K103120	Corin Biolox Delta Femoral Heads	Corin USA	2011	—
−6	K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	2011	—
−5	K111911	Corin Optimom Modular Head	Corin USA	2011	—
−4	K120362	Metafix Femoral Stem for Hemi-Arthroplasty	Corin USA	2012	—
−3	K121563	Corin Trifit TS Hip	Corin USA	2012	1
−2	K153772	Corin TriFit TS Hip	Corin U.S.A. Limited	2016	—
−1	K173880	Corin TriFit CF Hip Stem	Corin U.S.A. Limited	2018	—
0 (this device)	K201657	Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular…	Corin, Ltd.	2021	—
+1	K241472	Icona Hip Stem	Corin U.S.A. Limited	2024	—
+2	K261576	Icona Hip Stem	Corin, Ltd.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1981	1	0
1983	3	0
1984	1	0
1985	4	0
1986	6	0
1987	3	0
1988	3	0
1989	1	0
1990	5	0
1991	7	0
1992	7	0
1993	8	0
1994	34	0
1995	23	0
1996	23	0
1997	21	0
1998	17	0
1999	17	0
2000	32	0
2001	16	0
2002	18	0
2003	21	0
2004	13	0
2005	16	0
2006	8	0
2007	13	0
2008	5	0
2009	10	1
2010	13	0
2011	8	0
2012	6	0
2013	5	0
2014	2	0
2015	2	0
2016	3	0
2017	1	0
2018	1	0
2019	2	0
2020	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0
2026	1	0

FIG. 1 — Lineage of K201657, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (36)

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	Applicant	Decided	Recalls
*	K093472	Trinity Acetabular System Summary page 21 …WY, JDI, OQG, MBL, all class II Classification Panel: Orthopaedic Regulation Numbers: 21 CFR 888.3353, 888.3358, 888.3390, 888.3350, 888.3360 C. PREDICATE DEVICES K093472, K110087, Primary Predicate Device: K111481, K122305, Corin Trinity Acetabular System, including acetabular shells of…	Corin USA	2010	1
*	K110087	Corin Trinity Acetbular System with Hxlpe Liners Summary page 21 …OQG, MBL, all class II Classification Panel: Orthopaedic Regulation Numbers: 21 CFR 888.3353, 888.3358, 888.3390, 888.3350, 888.3360 C. PREDICATE DEVICES K093472, K110087, Primary Predicate Device: K111481, K122305, Corin Trinity Acetabular System, including acetabular shells of various…	Corin USA	2011	—
*	K111481	Corin Trinity Acetabular System Ecima Liners Summary page 21 …el: Orthopaedic Regulation Numbers: 21 CFR 888.3353, 888.3358, 888.3390, 888.3350, 888.3360 C. PREDICATE DEVICES K093472, K110087, Primary Predicate Device: K111481, K122305, Corin Trinity Acetabular System, including acetabular shells of various K123705, K130128, configurations, f…	Corin USA	2012	1
*	K122305	Corin Trinity-I Acetabular Shell Summary page 21 …hopaedic Regulation Numbers: 21 CFR 888.3353, 888.3358, 888.3390, 888.3350, 888.3360 C. PREDICATE DEVICES K093472, K110087, Primary Predicate Device: K111481, K122305, Corin Trinity Acetabular System, including acetabular shells of various K123705, K130128, configurations, femoral he…	Corin USA	2012	—
*	K123705	Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells Summary page 21 …0 C. PREDICATE DEVICES K093472, K110087, Primary Predicate Device: K111481, K122305, Corin Trinity Acetabular System, including acetabular shells of various K123705, K130128, configurations, femoral heads, bone screws, hole occluders, and K130343, K131647 HXLPE and ecima acetabula…	Corin USA	2013	4
*	K130128	Trinity Acetabular System Summary page 21 …DICATE DEVICES K093472, K110087, Primary Predicate Device: K111481, K122305, Corin Trinity Acetabular System, including acetabular shells of various K123705, K130128, configurations, femoral heads, bone screws, hole occluders, and K130343, K131647 HXLPE and ecima acetabular liners…	Corin Medical	2013	—
*	K130343	Corin Trinity Acetabular System with Extra-Long Heads Summary page 21 …05, Corin Trinity Acetabular System, including acetabular shells of various K123705, K130128, configurations, femoral heads, bone screws, hole occluders, and K130343, K131647 HXLPE and ecima acetabular liners Secondary Predicate Devices: K093472, K110087, Co…	Corin USA	2013	2
*	K131647	Trinity Acetabular System Summary page 21 …Corin Trinity Acetabular System, including acetabular shells of various K123705, K130128, configurations, femoral heads, bone screws, hole occluders, and K130343, K131647 HXLPE and ecima acetabular liners Secondary Predicate Devices: K093472, K110087, Corin CoCrM…	Corin USA	2013	—
*	K172551	Trinity PLUS Acetabular Shell Summary page 21 …acetabular liners Secondary Predicate Devices: K093472, K110087, Corin CoCrMo femoral heads, various diameters and offsets K130343, K131647 K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880…	Corin U.S.A. Limited	2018	—
*	K082525	Corin Metafix Femoral Stem Summary page 21 …Predicate Devices: K093472, K110087, Corin CoCrMo femoral heads, various diameters and offsets K130343, K131647 K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772…	Corin USA	2010	2
*	K120362	Metafix Femoral Stem for Hemi-Arthroplasty Summary page 21 …Devices: K093472, K110087, Corin CoCrMo femoral heads, various diameters and offsets K130343, K131647 K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin…	Corin USA	2012	—
*	K121439	Metafix Femoral Hip Stem Size 1 Summary page 21 …CoCrMo femoral heads, various diameters and offsets K130343, K131647 K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666,…	Corin USA	2012	—
*	K153381	Corin Metafix Hip Stem Summary page 21 …moral heads, various diameters and offsets K130343, K131647 K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Cor…	Corin U.S.A. Limited	2016	1
*	K173880	Corin TriFit CF Hip Stem Summary page 21 …ads, various diameters and offsets K130343, K131647 K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin Taper…	Corin U.S.A. Limited	2018	—
*	K121563	Corin Trifit TS Hip Summary page 21 …K172551 Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374…	Corin USA	2012	1
*	K153772	Corin TriFit TS Hip Summary page 21 …Corin PLUS Acetabular Shell K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Cori…	Corin U.S.A. Limited	2016	—
*	K992234	The Taper-Fit Total Hip System Summary page 21 …l K082525, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111…	Corin USA	1999	—
*	K003666	Taper-Fit Total Hip System Summary page 21 …, K120362, Corin MetaFix Hip System K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046,…	Corin USA	2001	—
*	K142761	Corin TaperFit Hip Stem Summary page 21 …K121439, K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120…	Corin USA	2015	1
*	K153725	Corin TaperFit Hip Stem Summary page 21 …K153381 K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Co…	Corin U.S.A. Limited	2016	—
*	K152903	REVIVAL (TM) Modular Revision Hip Stem Summary page 21 …K173880 Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biol…	Corin USA	2016	—
*	K191374	Revival Modular Hip Stem Summary page 21 …Corin TriFit CF Hip System K121563, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta…	Corin U.S.A. Limited	2019	—
*	K083312	Minihip Stem Summary page 21 …63, K153772 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trin…	Corin USA	2010	—
*	K111046	Corin Minihip Femoral Stem Summary page 21 …72 Corin TriFit TS Hip System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trinity Dual…	Corin USA	2011	—
*	K131986	Corin Minihip Stem Summary page 21 …System K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trinity Dual Mobility System K191831…	Corin USA	2013	—
*	K103120	Corin Biolox Delta Femoral Heads Summary page 21 …K992234, K003666, Corin TaperFit Hip System K142761, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trinity Dual Mobility System K191831…	Corin USA	2011	—
*	K170359	Trinity™ Dual Mobility System Summary page 21 …, K153725 K152903, K191374 Corin Revival Modular Hip System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trinity Dual Mobility System K191831 Corin MobiliT Cup K183114 Corin BiPola…	Corin U.S.A. Limited	2017	1
*	K191831	MobiliT Cup Summary page 21 …System K083312, K111046, Corin MiniHip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trinity Dual Mobility System K191831 Corin MobiliT Cup K183114 Corin BiPolar-i K000788 OMNI MOD Hip System (formerly A…	Corin U.S.A. Limited	2020	—
*	K183114	Corin BiPolar-i Summary page 21 …Hip K131986 K103120 Corin Biolox Delta femoral heads K170359 Corin Trinity Dual Mobility System K191831 Corin MobiliT Cup K183114 Corin BiPolar-i K000788 OMNI MOD Hip System (formerly Apex) K041950 OMNI K2 Hip S…	Corin U.S.A. Limited	2019	—
*	K000788	Apex Modular Hip Stem Summary page 21 …n Biolox Delta femoral heads K170359 Corin Trinity Dual Mobility System K191831 Corin MobiliT Cup K183114 Corin BiPolar-i K000788 OMNI MOD Hip System (formerly Apex) K041950 OMNI K2 Hip System (formerly Apex, now OMNI MOD) K060…	Apex Surgical, LLC	2000	—
*	K041950	Apex K2 Hip System Summary page 21 …rinity Dual Mobility System K191831 Corin MobiliT Cup K183114 Corin BiPolar-i K000788 OMNI MOD Hip System (formerly Apex) K041950 OMNI K2 Hip System (formerly Apex, now OMNI MOD) K060072, K110947 OMNI K1 Hip System K101451…	Apex Surgical, LLC	2004	1
*	K060072	Monoblock Press-Fit Hip Stem Summary page 21 …3114 Corin BiPolar-i K000788 OMNI MOD Hip System (formerly Apex) K041950 OMNI K2 Hip System (formerly Apex, now OMNI MOD) K060072, K110947 OMNI K1 Hip System K101451 OMNI Delta Ceramic Head (originally trade named Apex) K082468, K100151…	Omni Life Science, Inc.	2006	1
*	K110947	Apex K1 Hip Stem Summary page 21 …Corin BiPolar-i K000788 OMNI MOD Hip System (formerly Apex) K041950 OMNI K2 Hip System (formerly Apex, now OMNI MOD) K060072, K110947 OMNI K1 Hip System K101451 OMNI Delta Ceramic Head (originally trade named Apex) K082468, K100151 O…	Omni Life Science, Inc.	2011	—
*	K101451	Apex Module Hip System Biolox Delta Femoral Head Summary page 21 …8 OMNI MOD Hip System (formerly Apex) K041950 OMNI K2 Hip System (formerly Apex, now OMNI MOD) K060072, K110947 OMNI K1 Hip System K101451 OMNI Delta Ceramic Head (originally trade named Apex) K082468, K100151 OMNI Hip System Bipolar Head === P…	Omni Life Science, Inc.	2010	—
*	K082468	Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD… Summary page 21 …OMNI K2 Hip System (formerly Apex, now OMNI MOD) K060072, K110947 OMNI K1 Hip System K101451 OMNI Delta Ceramic Head (originally trade named Apex) K082468, K100151 OMNI Hip System Bipolar Head…	Omni Life Science, Inc.	2009	23
*	K100151	Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM) Summary page 21 …ip System (formerly Apex, now OMNI MOD) K060072, K110947 OMNI K1 Hip System K101451 OMNI Delta Ceramic Head (originally trade named Apex) K082468, K100151 OMNI Hip System Bipolar Head…	Omnlife Science	2010	—

Also cleared against K093472: 18 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K241472	Icona Hip Stem	Corin U.S.A. Limited	2024	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 40 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
98 of the 397 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K241472 (Corin U.S.A. Limited, 2024) has gone furthest, with 1 descendant of its own.
18 other devices also cite its predicate K093472.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The BiPolar-i is intended for use in the following indications: Non-innammatOI)' degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only. The Trinity…

Read the full statement (1,204 words)

The Trinity Acetabular System is indicated for use in non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental dysplasia of the hip (DOH) or congenital dysplasia of the hip (CDH). The Trinity Acetabular System is intended for cementless, single use only.

The indications for the Corin Meta FixTM Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:

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

· Rheumatoid arthritis

· Correction of functional deformity

· Treatment of non-union and femoral neck fractures

· Developmental dysplasia of the hip (DOH) and congenital dysplasia of the hip (CDH)

The Corin MetaFixTM Hip Stem is indicated for cementless use only.

The indications for the MiniHip Stem as a total hip arthroplasty include:· Non-innammatory degenerative joint disease including osteoarthritis and avascular necrosis· Rheumatoid arthritis· Correction of functional defom1ity· Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)The MiniHip Stem is indicated forcementless use only.

The indications for the TrinityT" Acetabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional defom1ity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acetabular System is intended for cementless, single use only.

The TriniryT" Dual Mobility System is intended for use in the following indications: I. Non-innammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional defonnity 4. Revision of previously failed total hip arthroplasry 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH). TI,e TrinityTM Dual Mobility System is indicated for cementless use only.

The indications for the Corin TrinityTM 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 t otal hip arthroplasty, Developmental dysplasia of the hip (DOH). The TrinityTM PLUS Acetabular Shell is indicated for cement less use only.

The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint:

- In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis

- For patients who have a high risk of dislocation

- In cases of necrosis of the femoral head

- In cases of fi-acture ofthe neck of the femur

- In cases of congenital luxation

The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup.

The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only.

The cemented MobiliT Cup is indicated for cemented use only.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur. Osteonecrosis of the femoral head, Revision procedures where other devices or treatments for these indications have failed.

The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acetabular System or bipolar component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

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

Rheumatoid arthritis;

• Correction of functional defom1ity;

• Congenital dislocation;

Revision procedures where other treatments or devices have failed;

• Femoral neck and trochanteric fractures of the proximal femur.

The indications for use of the- OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate:

Non-innammatory degenerative joint disease, including osteoarthritis a.nd avascular necrosis;

Rheumatoid arthritis;

Correction of functional deformity;

• Congenital dislocation;

- Revision procedures where other treatments or devices have failed;

Femoral neck and trochanteric fractures of the proximal femur.

The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The indications for use of the- OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate:

Non-innammatory degenerative joint disease, including osteoarthritis a.nd avascular necrosis;

Rheumatoid arthritis;

Correction of functional deformity;

• Congenital dislocation;

- Revision procedures where other treatments or devices have failed;

Femoral neck and trochanteric fractures of the proximal femur.

The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The Revival"" Modular Revision Hip Stem is indicated in rev,s,on surgery of femoral components, following failure of primary cemented or 1111-cemented prosthesis. T he REVIVAL™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival TM Modular Revision Hip Stem include: Non-innammatory degenerative joint disease including primary and secondary osteoarthritis, Rheumatoid arthritis, Correction of functional defonnity, Treatment of non-union and femoral neck fractures, Treatment oftraumatic dislocations ofthe hip, Failures ofosteotomy, Treatment ofarthrodesis. The Revival TM Modular Revision Hip Stem is indicated for cementless, single use only.

TaperFitTM Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The TaperFit Hip Stern is indicated for hemi-arthroplasty when used in combination with Corin hemi-arthroplasty femoral heads.

The TaperFitT" Hip Stern is indicated for cemented, single use only.

The indications for use of the K1 Hip Stem in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.

The K1 Hip Stem is indicated for cementless use only and single use implantation.

The indications for the Tri Fit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH), Previously failed hip surgery. The TriFit CF Hip Stem is indicated for cementless use only.

The indications for the Corin Tri Fit TS™ Hip as a total hip arthroplasry, and when used in combination with a Corin hemi arthroplast:y head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoa,thritis and avascular necrosis, Rheumatoid arthritis, Correction of functional defom1ity, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The TriFit TS Hip is intended for cementless use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201657

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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

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Has anything in its family been recalled? (1 Class I)

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Also cleared against K093472

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