510(k) · Cleared
Recalled · Class II · 2021Corin Trifit TS Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Oct 5, 2012 as substantially equivalent to K062994 (Biomet Manufacturing Corp, 2007) and 4 other predicates after a 129-day review. Its family tree reaches back 13 generations to 1981. 10 later devices descend from it. It has been recalled once.
- Decided
- Oct 5, 2012
- Review
- 129 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 13 generations to K810258 (1981). 125 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 1 generation backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- This deviceK121563 Corin Trifit TS HipCorin USA · 2012
- Descendant · cites it directly · 5 of its ownK153381 Corin Metafix Hip StemCorin U.S.A. Limited · 2016 · Recalled
- Descendant · cites it directly · 4 of its ownK153772 Corin TriFit TS HipCorin U.S.A. Limited · 2016
- Descendant · cites it directly · 3 of its ownK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
- Descendant · 2 generations on · 3 of its ownK162942 Corin MetaFix Hip StemCorin U.S.A. Limited · 2017
- Descendant · 2 generations on · 2 of its ownK212069 Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK111911 Corin Optimom Modular HeadCorin USA · 2011
- 1 generation backK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- This deviceK121563 Corin Trifit TS HipCorin USA · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K153381Corin Metafix Hip StemCorin U.S.A. Limited · 2016 · cites it directly5descendants
- K153772Corin TriFit TS HipCorin U.S.A. Limited · 2016 · cites it directly4descendants
- K173880Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018 · cites it directly3descendants
- K162942Corin MetaFix Hip StemCorin U.S.A. Limited · 2017 · 2 generations on3descendants
- K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −6 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −5 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −4 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −2 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| −1 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| 0 (this device) | K121563 | Corin Trifit TS Hip | Corin USA | 2012 | — |
| +1 | K153381 | Corin Metafix Hip Stem | Corin U.S.A. Limited | 2016 | 1 |
| +1 | K153772 | Corin TriFit TS Hip | Corin U.S.A. Limited | 2016 | — |
| +1 | K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018 | — |
| +2 | K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2017 | — |
| +2 | K212069 | Corin MetaFix™ Hip Stem | Corin U.S.A. Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K062994 | Lateralized Taperloc Microplasty Femoral ComponentsSummary page 1…to which Substantial Equivalence is claimed: * Biomet Laterlized Taperloc®g Microplasty Tm Femoral Components (1062994) * DePuy Titanium Tn-Lock Hip Stem (1(010367) * DePuy Tn-Lock Bone Preserva… | 2007 |
| * | K010367 | Modification to Titanium Tri-Lock Hips StemSummary page 1…* Biomet Laterlized Taperloc®g Microplasty Tm Femoral Components (1062994) * DePuy Titanium Tn-Lock Hip Stem (1(010367) * DePuy Tn-Lock Bone Preservation Stem (K(073570) m Corkn Metafix Hip Stem… | 2001 |
| * | K073570 | Depuy Tri-Lock Bone Preservation StemSummary page 1…Components (1062994) * DePuy Titanium Tn-Lock Hip Stem (1(010367) * DePuy Tn-Lock Bone Preservation Stem (K(073570) m Corkn Metafix Hip Stem with Hemi-Arthroplasty (120362) 0Corin Trinity A… | 2008 |
| * | K120362 | Metafix Femoral Stem for Hemi-ArthroplastySummary page 1…Stem (1(010367) * DePuy Tn-Lock Bone Preservation Stem (K(073570) m Corkn Metafix Hip Stem with Hemi-Arthroplasty (120362) 0Corin Trinity Acetabular System (1(093472) 8. Device Description: The Corkn TriFit TS Hip… | 2012 |
| * | K093472 | Trinity Acetabular SystemSummary page 2…in materials. The coating of titanium plasma spray with a layer ofcalcium phosphate(BONIT®) is similar to the coating for the Corkn Trinity Acetabular System. (K093472) in terms of materials and performance. Based on these siiarities, the TriFit TS H-ip is believed to be substantially e… | 2010 |
What descends from it? (10)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2021 | Class II | Z-2603-2021 | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 28 of the 124 ancestors have a recall of any class.
- Of its descendants, K153381 (Corin U.S.A. Limited, 2016) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K062994.
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. 2012, 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 TS Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The TriFit TS Hip is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121563: Corin Trifit TS Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121563
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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