510(k) · Cleared
ClearedTRIVANCE™ Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 4, 2026 as substantially equivalent to K190276 (Stelkast, Inc., 2019) and 8 other predicates after a 230-day review. Its family tree reaches back 18 generations to 1994.
- Decided
- Aug 4, 2026
- Review
- 230 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 18 generations to K941847 (1994). 210 ancestors in all, the oldest K802627 (1980). No later device cites it as a predicate yet.
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations between
- 3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 1 generation backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- This deviceK254043 TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 17 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 16 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 15 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 14 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 13 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 12 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 11 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 10 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 9 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 8 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 7 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 6 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 5 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 4 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 1 generation backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- This deviceK254043 TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −17 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −16 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −15 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −14 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −13 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −12 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −11 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −10 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −9 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −8 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −7 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −6 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −5 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −4 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −3 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −2 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −1 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| 0 (this device) | K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 22 | 0 |
| 1995 | 17 | 0 |
| 1996 | 13 | 0 |
| 1997 | 8 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 22 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K190276 | Provident II Hip StemSummary page 5…Product Codes: LPH, JDI, LWJ, LZO, OQH, OQI, KWY Regulatory Class: II, Panel Code: 87 Primary Predicate: PROVIDENT II (K190276) Additional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K00198… | 2019 |
| * | K210581 | Actis DuoFix Hip Prosthesis- CollarlessSummary page 5…LZO, OQH, OQI, KWY Regulatory Class: II, Panel Code: 87 Primary Predicate: PROVIDENT II (K190276) Additional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K22021… | 2021 |
| * | K202472 | ACTIS Duofix Hip ProsthesisSummary page 5…, OQI, KWY Regulatory Class: II, Panel Code: 87 Primary Predicate: PROVIDENT II (K190276) Additional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K08223… | 2020 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…Y Regulatory Class: II, Panel Code: 87 Primary Predicate: PROVIDENT II (K190276) Additional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K082239, K98291… | 2016 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: PROVIDENT II (K190276) Additional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K082239, K982918) Purpos… | 2015 |
| * | K001984 | Progeny Forged Cocr Cemented Femoral ComponentSummary page 5…imary Predicate: PROVIDENT II (K190276) Additional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K082239, K982918) Purpose: The purpose of this submission is to request cleara… | 2000 |
| * | K220216 | C-Stem AMT LE ProsthesisSummary page 5…dditional Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K082239, K982918) Purpose: The purpose of this submission is to request clearance for TRIVANCE™ hip stem implants. Device Descr… | 2022 |
| * | K082239 | Depuy C-Stem AmtSummary page 5…Predicates: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K082239, K982918) Purpose: The purpose of this submission is to request clearance for TRIVANCE™ hip stem implants. Device Description: T… | 2008 |
| * | K982918 | Depuy C-Stem SystemSummary page 5…es: DePuy Actis (K210581, K202472, K160907, K150862) StelKast Progeny (K001984) DePuy C-Stem (K220216, K082239, K982918) Purpose: The purpose of this submission is to request clearance for TRIVANCE™ hip stem implants. Device Description: The TRIVAN… | 1998 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 49 of the 209 ancestors have a recall of any class.
- 1 other device also cites its predicate K190276.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The TRIVANCE™ stems are intended for total and hemi-hip arthroplasty in skeletally mature patients for the following indications:
1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
The TRIVANCE™ stems are intended for cemented and uncemented applications.
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/K254043 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254043: TRIVANCE™ 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/K254043
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026