510(k) · Cleared
ClearedTaper-Fit Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Feb 8, 2001 as substantially equivalent to K992234 (Corin USA, 1999) after a 72-day review. Its family tree reaches back 1 generation to 1999. 118 later devices descend from it.
- Decided
- Feb 8, 2001
- Review
- 72 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992234 (1999). 118 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK992234 The Taper-Fit Total Hip SystemCorin USA · 1999
- This deviceK003666 Taper-Fit Total Hip SystemCorin USA · 2001
- Descendant · cites it directly · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · cites it directly · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · cites it directly · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 2 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K093472Trinity Acetabular SystemCorin USA · 2010 · cites it directly117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · cites it directly62descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · cites it directly61descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 2 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992234 | The Taper-Fit Total Hip System | Corin USA | 1999 | — |
| 0 (this device) | K003666 | Taper-Fit Total Hip System | Corin USA | 2001 | — |
| +1 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +1 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +1 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 10 | 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? (1)
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 |
|---|---|---|---|
| * | K992234 | The Taper-Fit Total Hip SystemSummary page 1…on is to gain clearance to market cobalt-chrome modular femoral heads and zirconia ceramic modular femoral heads with the previously approved Taper-Fit Total Hip System (K992234). Substantial equivalence (SE) is claimed, herein, to the Taper-Fit Hip System as it was previously approved for use with stainl… | 1999 |
What descends from it? (118)
See all 1186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093472 | Trinity Acetabular System | 2010 | 117 |
| K111911 | Corin Optimom Modular Head | 2011 | 62 |
| K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | 2012 | 61 |
| K142761 | Corin TaperFit Hip Stem | 2015 | 4 |
| K153725 | Corin TaperFit Hip Stem | 2016 | 3 |
| 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?
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.
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?
Taper-Fit Total Hip System 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.
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/K003666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003666: Taper-Fit Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003666
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026