510(k) · Cleared
ClearedTrivicta® Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on May 22, 2025 as substantially equivalent to K233758 (Ortho Development Corp., 2024) and 1 other predicate after a 49-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- May 22, 2025
- Review
- 49 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K941847 (1994). 268 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations between
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK233758 Trivicta™ Hip StemOrtho Development Corp. · 2024
- This deviceK251052 Trivicta® Hip StemOrtho Development Corp. · 2025
Show all 16 generations
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 14 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 13 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 12 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 11 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 10 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 9 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 7 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 5 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 4 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK233758 Trivicta™ Hip StemOrtho Development Corp. · 2024
- This deviceK251052 Trivicta® Hip StemOrtho Development Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −15 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −14 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −13 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −12 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −11 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −10 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −9 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −7 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −5 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −4 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −2 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −1 | K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024 | — |
| 0 (this device) | K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 27 | 0 |
| 1995 | 15 | 0 |
| 1996 | 19 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 13 | 0 |
| 2000 | 28 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K233758 | Trivicta™ Hip StemSummary page 5…metallic cemented or uncemented prosthesis Device Class: Class II Primary Predicate Ortho Development® Trivicta® (K233758) Device: Reference Predicate DepuySynthes Actis DuoFix Hip Prosthesis (K150862) Device:… | 2024 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…Class II Primary Predicate Ortho Development® Trivicta® (K233758) Device: Reference Predicate DepuySynthes Actis DuoFix Hip Prosthesis (K150862) Device: K251052 Page… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 63 of the 267 ancestors have a recall of any class.
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. 2025, 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?
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251052: Trivicta® Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251052
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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