510(k) · Cleared
Recalled · Class II · 2015Trident Acetabular 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 Feb 10, 2005 after a 442-day review. The FDA summary names its predicate without a number. 64 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 10, 2005
- Review
- 442 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 0
64 later devices descend from it, 5 citing it directly.
- This deviceK033716 Trident Acetabular SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 54 of its ownK061434 Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · Recalled
- Descendant · 2 generations on · 37 of its ownK110290 Exeter Hip StemHowmedica Osteonics Corp. · 2011 · Recalled
- Descendant · cites it directly · 23 of its ownK062419 Trident Large Diameter Acetabular InsertsHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 2 generations on · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · cites it directly54descendants
- K110290Exeter Hip StemHowmedica Osteonics Corp. · 2011 · 2 generations on37descendants
- K062419Trident Large Diameter Acetabular InsertsHowmedica Osteonics Corp. · 2006 · cites it directly23descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033716 | Trident Acetabular System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K061434 | Trident Large Diameter Hip System | Howmedica Osteonics Corp. | 2006 | 2 |
| +2 | K110290 | Exeter Hip Stem | Howmedica Osteonics Corp. | 2011 | 1 |
| +1 | K062419 | Trident Large Diameter Acetabular Inserts | Howmedica Osteonics Corp. | 2006 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +2 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 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 24.3 · 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? (1)
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 |
|---|---|---|---|
| * | — | Trident® Hip System Named without a submission number |
What descends from it? (64)
See all 645 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061434 | Trident Large Diameter Hip System | 2006 | 54 |
| K062419 | Trident Large Diameter Acetabular Inserts | 2006 | 23 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | 2019 | 7 |
| K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2015 | Class II | Z-2810-2015 | Nonconforming Material/Component | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. |
| Feb 17, 2006 | Not classified | Z-0909-2010 | Process design | Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061434 (Howmedica Osteonics Corp., 2006) has gone furthest, with 54 descendants of its own.
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?
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances: Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis…
Read the full statement (114 words)
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances:
Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous failed femnoral 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033716: Trident Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033716
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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