510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Corin TaperFit Hip Stem

K142761510(k) TraditionalCleared Apr 3, 2015190-day reviewClass II21 CFR 888.3350Recalls 1

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

Corin USA · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Apr 3, 2015 as substantially equivalent to K992234 (Corin USA, 1999) and 13 other predicates after a 190-day review. Its family tree reaches back 13 generations to 1981. 4 later devices descend from it. It has been recalled once.

Decided
Apr 3, 2015
Review
190 days
Class
Class II
Product code
JDI
Recalls
1
Predicates
14

Its longest line of descent runs back 13 generations to K810258 (1981). 136 ancestors in all, the oldest K803126 (1981). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 3 other ancestors2012: 1 other ancestor2011: 1 other ancestor2010: 1 other ancestor2001: 9 other ancestors1999: 5 other ancestors1989: 1 other ancestor1981: 1 other ancestor2009: 2 other ancestors2007: 1 other ancestor2006: 2 other ancestors2005: 4 other ancestors2004: 7 other ancestors2003: 4 other ancestors2002: 10 other ancestors2000: 15 other ancestors1997: 8 other ancestors1996: 7 other ancestors1995: 9 other ancestors1994: 12 other ancestors1991: 3 other ancestors1998: 5 other ancestors1990: 2 other ancestors1985: 2 other ancestors1993: 2 other ancestors1988: 1 other ancestor1984: 1 other ancestor1992: 2 other ancestors1987: 1 other ancestor2021: 1 descendant cleared2016: 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), K123705 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 19 other ancestors3 generations back: 30 other ancestors4 generations back: 23 other ancestors5 generations back: 19 other ancestors6 generations back: 8 other ancestors7 generations back: 10 other ancestors8 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K123705 · Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells · Corin USA · 2013 · recalledK122305 · 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 backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
  6. This deviceK142761 Corin TaperFit Hip StemCorin USA · 2015
  7. Descendant · cites it directly · 3 of its ownK153725 Corin TaperFit Hip StemCorin U.S.A. Limited · 2016
  8. Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
  9. Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
  10. Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
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 backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
  14. This deviceK142761 Corin TaperFit Hip StemCorin USA · 2015

Most influential descendants

Showing 4 of 4 · See all
  • K153725Corin TaperFit Hip StemCorin U.S.A. Limited · 2016 · cites it directly3descendants
  • 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
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—
−1K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA20134
0 (this device)K142761Corin TaperFit Hip StemCorin USA2015—
+1K153725Corin TaperFit Hip StemCorin U.S.A. Limited2016—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198520
198710
198810
198910
199020
199130
199220
199320
1994120
199590
199670
199780
199850
199950
2000150
200190
2002100
200340
200470
200540
200620
200710
200920
201010
201110
201210
201330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202110
202410
202610
FIG. 1 — Lineage of K142761, 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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? (14)

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
*K992234The Taper-Fit Total Hip System
Summary page 4
…50: Hip joint metal/polymer semi-constrained cemented prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K0934…
Corin USA1999—
*K003666Taper-Fit Total Hip System
Summary page 4
…oint metal/polymer semi-constrained cemented prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K1100…
Corin USA2001—
*K803126Exeter Total Hip System
Summary page 4
…esis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343…
Howmedica Corp.1981—
*K891454Exeter II Total Hip System
Summary page 4
…Legally Marketed Devices to which Substantial Equivalence is claimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131…
Howmedica Corp.1989—
*K011623Exeter Hip System with V40 Taper
Summary page 4
…arketed Devices to which Substantial Equivalence is claimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  =…
Howmedica Osteonics Corp.2001—
*K110290Exeter Hip Stem
Summary page 4
…es to which Substantial Equivalence is claimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) …
Howmedica Osteonics Corp.20111
*K093472Trinity Acetabular System
Summary page 4
…aimed: x Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) …
Corin USA20101
*K110087Corin Trinity Acetbular System with Hxlpe Liners
Summary page 4
…Corin Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) …
Corin USA2011—
*K111481Corin Trinity Acetabular System Ecima Liners
Summary page 4
…Taper-Fit Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  K142…
Corin USA20121
*K122305Corin Trinity-I Acetabular Shell
Summary page 4
…Hip Stem (K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  K142761 Page…
Corin USA2012—
*K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells
Summary page 4
…(K992234, K003666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  K142761 Page 2 of 3…
Corin USA20134
*K130128Trinity Acetabular System
Summary page 4
…03666) x Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  K142761 Page 2 of 3  9. Device D…
Corin Medical2013—
*K130343Corin Trinity Acetabular System with Extra-Long Heads
Summary page 4
…Howmedica / Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  K142761 Page 2 of 3  9. Device Descriptio…
Corin USA20132
*K131647Trinity Acetabular System
Summary page 4
…/ Stryker Exeter Hip Stem (K803126, K891454, K011623, and K110290) x Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647)  K142761 Page 2 of 3  9. Device Description: The Corin…
Corin USA2013—

Also cleared against K992234: 3 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
K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 12, 2022Class IIZ-1667-2022Under Investigation by firmSome of the devices did not pass fatigue testing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 33 of the 135 ancestors have a recall of any class.
  • Of its descendants, K153725 (Corin U.S.A. Limited, 2016) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K992234.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following

the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects,

avascular necrosis and total hip revision.

The TaperFit Hip Stem is indicated for cemented, single use only.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K142761: Corin TaperFit Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142761

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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