510(k) Report

510(k) · Cleared

Cleared

Trinity Acetabular System

K103518510(k) TraditionalCleared Mar 9, 201199-day reviewClass II21 CFR 888.3360

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

Corin USA · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Mar 9, 2011 as substantially equivalent to K093472 (Corin USA, 2010) and 2 other predicates after a 99-day review. Its family tree reaches back 9 generations to 1996. 8 later devices descend from it.

Decided
Mar 9, 2011
Review
99 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K955033 (1996). 108 ancestors in all, the oldest K840643 (1984). 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2008: 1 other ancestor2005: 5 other ancestors2004: 2 other ancestors2003: 7 other ancestors2001: 4 other ancestors2000: 8 other ancestors1999: 3 other ancestors2007: 1 other ancestor2006: 2 other ancestors2002: 4 other ancestors1998: 6 other ancestors1997: 6 other ancestors1996: 11 other ancestors1994: 12 other ancestors1990: 2 other ancestors1984: 1 other ancestor1995: 9 other ancestors1993: 2 other ancestors1992: 3 other ancestors1991: 3 other ancestors1987: 2 other ancestors1985: 2 other ancestors2013: 2 descendants cleared2017: 2 descendants cleared2022: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996K983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002×2: 2 generations cleared close together, K040191 (2004), K043079 (2004) K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006K080584 · Metha Short Stem Hip System · Aesculap Implant System, Inc. · 2008K083312 · Minihip Stem · Corin USA · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 9 other ancestors3 generations back: 16 other ancestors4 generations back: 22 other ancestors5 generations back: 30 other ancestors6 generations back: 17 other ancestors7 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 1 descendant K083312 · Minihip Stem · Corin USA · 2010K080584 · Metha Short Stem Hip System · Aesculap Implant System, Inc. · 2008K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006K043079 · Bicontact Hip System with U-Cap · Aesculap · 2004K040191 · Bicontact Hip Stem and Femoral Head · Aesculap · 2004K022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996−50
  1. Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 5 generations between
  3. 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  4. 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  5. 1 generation backK083312 Minihip StemCorin USA · 2010
  6. This deviceK103518 Trinity Acetabular SystemCorin USA · 2011
  7. Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  8. Descendant · 2 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
  9. Descendant · 2 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
  10. Descendant · 2 generations on · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
  11. Descendant · 2 generations on · 2 of its ownK170089 U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017
Show all 9 generations
  1. Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 8 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
  3. 7 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
  4. 6 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  5. 5 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. 4 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
  7. 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  8. 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  9. 1 generation backK083312 Minihip StemCorin USA · 2010
  10. This deviceK103518 Trinity Acetabular SystemCorin USA · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2013: 22017: 22018: 12022: 12023: 12026: 1
2013high 2 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 8 · See all
  • K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
  • K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 2 generations on3descendants
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 2 generations on3descendants
  • K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · 2 generations on2descendants
  • K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K955033Rim Flare Acetabular ComponentIntermedics Orthopedics1996—
−8K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999—
−7K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003
−6K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
−5K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
−4K043079Bicontact Hip System with U-CapAesculap2004—
−3K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
−2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—
−1K083312Minihip StemCorin USA2010—
0 (this device)K103518Trinity Acetabular SystemCorin USA2011—
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.2013—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.2013—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198520
198720
199020
199130
199230
199320
1994120
199590
1996110
199760
199860
199930
200080
200140
200240
200370
200420
200550
200620
200710
200810
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201720
201810
202210
202310
202610
FIG. 1 — Lineage of K103518, 1996–2026Source: 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (3)

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 1
…nted prosthesis (21CFR 888.3353) 6. Legally Marketed Devices to which Substantial Equivalence is claimed: * Corin Trinity Acetabular System (K(093472) a Corin Metafix Femoral Stem (1(082525) * Coriri Mii-lip Femoral Stem (K(0…
Corin USA20101
*K082525Corin Metafix Femoral Stem
Summary page 1
…ich Substantial Equivalence is claimed: * Corin Trinity Acetabular System (K(093472) a Corin Metafix Femoral Stem (1(082525) * Coriri Mii-lip Femoral Stem (K(083312) 7. Device Descriptioni: The Trinity Acetabular Syst…
Corin USA20102
*K083312Minihip Stem
Summary page 1
…Corin Trinity Acetabular System (K(093472) a Corin Metafix Femoral Stem (1(082525) * Coriri Mii-lip Femoral Stem (K(083312) 7. Device Descriptioni: The Trinity Acetabular System is a modular acetabular cup system consisting of a press f…
Corin USA2010—

Also cleared against K093472: 18 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137

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 15 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
  • 26 of the 107 ancestors have a recall of any class.
  • Of its descendants, K122185 (United Orthopedic Corp., 2013) has gone furthest, with 7 descendants of its own.
  • 18 other devices also cite its predicate K093472.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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
20072—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

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) 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.

Cite this page

510(k) Report. “K103518: Trinity Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103518

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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