510(k) · Cleared
ClearedTrident T Acetabular Shells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 25, 2004 as substantially equivalent to K010170 (Howmedica Osteonics Corp., 2001) and 4 other predicates after a 97-day review. Its family tree reaches back 5 generations to 1994. 23 later devices descend from it.
- Decided
- May 25, 2004
- Review
- 97 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K941141 (1994). 25 ancestors in all, the oldest K903362 (1990). 23 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 4 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- 3 generations backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- 2 generations backK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- 1 generation backK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
- This deviceK040412 Trident T Acetabular ShellsStryker Orthopaedics · 2004
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- 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 · 2 generations on7descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
- K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −4 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| −3 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| −2 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| −1 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
| 0 (this device) | K040412 | Trident T Acetabular Shells | Stryker Orthopaedics | 2004 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| +2 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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 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? (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 |
|---|---|---|---|
| * | K010170 | Trident Porous Titanium Acetabular ComponentSummary page 1…E-Mail: Ginnv. Stambergc1-(wstryker. corn Date Summary Prepared: Februarv 17. 2004 Identification of Predicates 1. K010170 - Trident® Porous Titanium 2. KOI 3475 - Tridenri® Porous Titanium… | 2001 |
| * | K013475 | Trident Porous Titanium Acetabular Component with Peri-Apatite Coating | 2001 |
| * | K983502 | Osteonics Secur-Fit AD Generation II Acetabular Component SystemSummary page 2…e 2 === Tridcrit' "T" Acetab~idav Shells 51 0(k) P'rviarket Notification 4 3. 1(983502 - Osteonics Secur-FIl-AD Genieration 11 Acetabular Componients 4. K983382 - formerly designated as Osteonics Generation 11 A… | 1998 |
| * | K983382 | Osteonics HA Generation II Acetabular Component SystemSummary page 2…51 0(k) P'rviarket Notification 4 3. 1(983502 - Osteonics Secur-FIl-AD Genieration 11 Acetabular Componients 4. K983382 - formerly designated as Osteonics Generation 11 Acetabuilar Compolietits 5.K013676 - Trident® AD and AD/HA Hemispherical… | 1998 |
| * | K013676 | Trident Hemispherical Acetabular ShellsSummary page 2…983502 - Osteonics Secur-FIl-AD Genieration 11 Acetabular Componients 4. K983382 - formerly designated as Osteonics Generation 11 Acetabuilar Compolietits 5.K013676 - Trident® AD and AD/HA Hemispherical Acetabtilar Shells Device Description The subject devices are identical to their correspo… | 2001 |
What descends from it? (23)
See all 234 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)
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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 25 ancestors have a recall of any class.
- Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
- 8 other devices also cite its predicate K010170.
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 Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws. Indications · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid…
Read the full statement (120 words)
The Trident® Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
Indications
· 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 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/K040412 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040412: Trident T Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040412
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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