510(k) · Cleared
ClearedTrident Porous Titanium Acetabular Component with Peri-Apatite Coating
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 Dec 20, 2001 as substantially equivalent to K010170 (Howmedica Osteonics Corp., 2001) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1998. 216 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971206 (1998). 2 ancestors in all. 216 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971206 Meridian ST Femoral Stem and Vitalock Solid Back Shell W/…Howmedica Corp. · 1998 · Recalled
- This deviceK013475 Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 2 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
Showing 5 of 216 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 216 · See all- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 2 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating | Howmedica Corp. | 1998 | 1 |
| 0 (this device) | K013475 | Trident Porous Titanium Acetabular Component with Peri-Apatite Coating | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 15 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 13 | 0 |
| 2018 | 10 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 18 | 0 |
| 2022 | 16 | 0 |
| 2023 | 14 | 0 |
| 2024 | 10 | 0 |
| 2025 | 21 | 0 |
| 2026 | 16 | 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? (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 |
|---|---|---|---|
| * | K010170 | Trident Porous Titanium Acetabular ComponentSummary page 4…Page 4 === KQI3Y1s Pe YofF Y 510(k) Summary Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating 1) Trident® Porous Titanium Acetabular Component — K010170 Howmedica Osteonics Corp. 2) Vitalock® Solid Back Shell with Peri-Apatite™ Coating — K971206 A discussion of the equivalent fea… | 2001 |
| * | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite CoatingSummary page 4…Peri-Apatite™ Coating 1) Trident® Porous Titanium Acetabular Component — K010170 Howmedica Osteonics Corp. 2) Vitalock® Solid Back Shell with Peri-Apatite™ Coating — K971206 A discussion of the equivalent features was presented. For further information please contact: Margaret F. Crowe Regulatory Affa… | 1998 |
What descends from it? (216)
See all 2162 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?
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 indications for use of the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, in keeping with those of other legally marketed Howmedica Osteonics acetabular component systems, are as follows: e Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis. ¢ Clinical management problems where arthrodesis or alternative reconstructive techniques are…
Read the full statement (100 words)
The indications for use of the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, in keeping with those of other legally marketed Howmedica Osteonics acetabular component systems, are as follows:
e Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis.
¢ Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
e Revision of previously unsuccessful femoral head replacement, cup arthroplasty or other procedure.
¢ Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
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/K013475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013475: Trident Porous Titanium Acetabular Component with Peri-Apatite Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013475
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026