510(k) · Cleared
Recalled · 2009Trident Large Diameter Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 22, 2006 as substantially equivalent to K021310 (Howmedica Osteonics Corp., 2002) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1996. 54 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 22, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 3 generations to K955033 (1996). 13 ancestors in all, the oldest K900836 (1990). 54 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 2 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 1 generation backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- This deviceK061434 Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 37 of its ownK110290 Exeter Hip StemHowmedica Osteonics Corp. · 2011 · Recalled
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · cites it directly · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · cites it directly · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K110290Exeter Hip StemHowmedica Osteonics Corp. · 2011 · cites it directly37descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · cites it directly16descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −2 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −1 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| 0 (this device) | K061434 | Trident Large Diameter Hip System | Howmedica Osteonics Corp. | 2006 | — |
| +1 | K110290 | Exeter Hip Stem | Howmedica Osteonics Corp. | 2011 | 1 |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +1 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +1 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 24.2 · 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? (4)
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 |
|---|---|---|---|
| * | K021310 | 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Summary page 2…quivalence: The LFIT femoral heads and Trident® large diameter acetabular inserts are substantially equivalent to Howmedica Osteonics' LFIT cobalt chrome femoral heads, K021310 and K022077, Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K993259, and Howmedica Osteonics' Trident® acetab… | 2002 |
| * | K022077 | 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Summary page 2…The LFIT femoral heads and Trident® large diameter acetabular inserts are substantially equivalent to Howmedica Osteonics' LFIT cobalt chrome femoral heads, K021310 and K022077, Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K993259, and Howmedica Osteonics' Trident® acetabular system,… | 2002 |
| * | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSummary page 2…ubstantially equivalent to Howmedica Osteonics' LFIT cobalt chrome femoral heads, K021310 and K022077, Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K993259, and Howmedica Osteonics' Trident® acetabular system, K033716. 4 === Page 3 ==… | 2000 |
| * | K033716 | Trident Acetabular SystemSummary page 2…rome femoral heads, K021310 and K022077, Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K993259, and Howmedica Osteonics' Trident® acetabular system, K033716. 4 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2005 |
What descends from it? (54)
See all 544 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 |
|---|---|---|---|---|
| Sep 4, 2009 | Not classified | Z-0390-2010 | Process control | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. |
| Sep 4, 2009 | Not classified | Z-0391-2010 | Process control | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K110290 (Howmedica Osteonics Corp., 2011) has gone furthest, with 37 descendants of its own.
- 1 other device also cites its predicate K021310.
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.
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?
Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061434: Trident Large Diameter Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061434
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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