510(k) · Cleared
ClearedCorin TaperFit Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 25, 2016 as substantially equivalent to K142761 (Corin USA, 2015) and 2 other predicates after an 88-day review. Its family tree reaches back 14 generations to 1981. 3 later devices descend from it.
- Decided
- Mar 25, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K810258 (1981). 137 ancestors in all, the oldest K803126 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations between
- 3 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 2 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 1 generation backK142761 Corin TaperFit Hip StemCorin USA · 2015 · Recalled
- This deviceK153725 Corin TaperFit Hip StemCorin U.S.A. Limited · 2016
- Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
Show all 14 generations
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 3 generations backK122305 Corin Trinity-I Acetabular ShellCorin USA · 2012
- 2 generations backK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- 1 generation backK142761 Corin TaperFit Hip StemCorin USA · 2015 · Recalled
- This deviceK153725 Corin TaperFit Hip StemCorin U.S.A. Limited · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −13 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −12 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −11 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −10 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −9 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −8 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −7 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −6 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −5 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −3 | K122305 | Corin Trinity-I Acetabular Shell | Corin USA | 2012 | — |
| −2 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| −1 | K142761 | Corin TaperFit Hip Stem | Corin USA | 2015 | 1 |
| 0 (this device) | K153725 | Corin TaperFit Hip Stem | Corin U.S.A. Limited | 2016 | — |
| +1 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +2 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +3 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 15 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 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 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142761 | Corin TaperFit Hip StemSummary page 4…t femoral (hemi-hip) metallic cemented or uncemented prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: Corin TaperFit Hip Stem (K142761) Corin Taper-Fit Hip Stem (K992234, K003666)… | 2015 |
| * | K992234 | The Taper-Fit Total Hip SystemSummary page 4…uncemented prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: Corin TaperFit Hip Stem (K142761) Corin Taper-Fit Hip Stem (K992234, K003666) -----------… | 1999 |
| * | K003666 | Taper-Fit Total Hip SystemSummary page 4…d prosthesis 8. Legally Marketed Devices to which Substantial Equivalence is claimed: Corin TaperFit Hip Stem (K142761) Corin Taper-Fit Hip Stem (K992234, K003666) -----------… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… | 2021 | 2 |
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 35 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 34 of the 136 ancestors have a recall of any class.
- Of its descendants, K201657 (Corin, Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K142761.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The TaperFit 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 Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads.
The TaperFit Hip Stem is indicated for cemented, single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153725: 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/K153725
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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