510(k) · Cleared
ClearedCorin TriFit CF Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Apr 11, 2018 as substantially equivalent to K141001 (Ortho Development, 2014) and 2 other predicates after a 111-day review. Its family tree reaches back 15 generations to 1981. 3 later devices descend from it.
- Decided
- Apr 11, 2018
- Review
- 111 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K810258 (1981). 179 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- 2 generations backK121563 Corin Trifit TS HipCorin USA · 2012 · Recalled
- 1 generation backK153772 Corin TriFit TS HipCorin U.S.A. Limited · 2016
- This deviceK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
- Descendant · cites it directly · 2 of its ownK201657 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 15 generations
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 13 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 12 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 11 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 10 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 9 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 8 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 7 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 6 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 5 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 4 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 3 generations backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- 2 generations backK121563 Corin Trifit TS HipCorin USA · 2012 · Recalled
- 1 generation backK153772 Corin TriFit TS HipCorin U.S.A. Limited · 2016
- This deviceK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
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 |
|---|---|---|---|---|---|
| −15 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −14 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −13 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −12 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −11 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −10 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −9 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −8 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −7 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −6 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −5 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −4 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| −3 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| −2 | K121563 | Corin Trifit TS Hip | Corin USA | 2012 | 1 |
| −1 | K153772 | Corin TriFit TS Hip | Corin U.S.A. Limited | 2016 | — |
| 0 (this device) | K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018 | — |
| +1 | 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 |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 25 | 0 |
| 1995 | 9 | 0 |
| 1996 | 13 | 0 |
| 1997 | 12 | 0 |
| 1998 | 5 | 0 |
| 1999 | 10 | 0 |
| 2000 | 16 | 0 |
| 2001 | 10 | 0 |
| 2002 | 11 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K141001 | Alpine Hip Stem; Alpine HA Hip StemSummary page 4…(21CFR 888.3360) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: Ortho Development Corporation Alpine Hip Stem (K141001) (Primary predicate) Corin TriFit™ TS Hip (K121563 and K153772) 9. Device Description: The Corin TriFit™ CF Hip Stem… | 2014 |
| * | K121563 | Corin Trifit TS HipSummary page 4…ices to which Substantial Equivalence is claimed: Ortho Development Corporation Alpine Hip Stem (K141001) (Primary predicate) Corin TriFit™ TS Hip (K121563 and K153772) 9. Device Description: The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6… | 2012 |
| * | K153772 | Corin TriFit TS HipSummary page 4…h Substantial Equivalence is claimed: Ortho Development Corporation Alpine Hip Stem (K141001) (Primary predicate) Corin TriFit™ TS Hip (K121563 and K153772) 9. Device Description: The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6Al4V) (ASTM… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 37 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 36 of the 178 ancestors have a recall of any class.
- Of its descendants, K201657 (Corin, Ltd., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The indications for the Corin TriFit™ 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 of the proximal femur
Developmental Dysplasia of the Hip (DDH)
Previously failed hip surgery
The Corin TriFit™ CF Hip Stem is indicated for cementless 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/K173880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173880: Corin TriFit CF 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/K173880
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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