510(k) · Cleared
ClearedTrident Acetabular Shells: PS-HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Aug 4, 2000 as substantially equivalent to K983382 (Osteonics Corp., 1998) and 3 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1994. 150 later devices descend from it.
- Decided
- Aug 4, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K941141 (1994). 13 ancestors in all, the oldest K903362 (1990). 150 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 2 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- 1 generation backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- This deviceK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 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 · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 68 of its ownK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
- Descendant · 3 generations on · 63 of its ownK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
Showing 5 of 150 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 150 · See all- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · cites it directly90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 2 generations on68descendants
- K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · cites it directly68descendants
- K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008 · 3 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −2 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| −1 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| 0 (this device) | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +1 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
| +3 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K983382 | Osteonics HA Generation II Acetabular Component SystemSummary page 1…nt Components - Acetabular Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis 21 CFR §888.3353 . Trident Acetabular Shells (K983382 - originally called the "Osteonics HA Generation II Acetabular Component System") . Osteolock NP and Osteolock Cluster Acetabul… | 1998 |
| * | K971854 | Osteolock Acetabular Shell SystemSummary page 1…nt Acetabular Shells (K983382 - originally called the "Osteonics HA Generation II Acetabular Component System") . Osteolock NP and Osteolock Cluster Acetabular Shells (K971854 and K933102) . Citation TMZF HA Hip Stems (K993768) Device Description The subject Trident Acetabular Shells are characterized… | 1997 |
| * | K933102 | Howmedica Acetabular Shell W/Screw HolesSummary page 1…r Shells (K983382 - originally called the "Osteonics HA Generation II Acetabular Component System") . Osteolock NP and Osteolock Cluster Acetabular Shells (K971854 and K933102) . Citation TMZF HA Hip Stems (K993768) Device Description The subject Trident Acetabular Shells are characterized by the foll… | 1994 |
| * | K993768 | Citation TMZF HA StemSummary page 1…e "Osteonics HA Generation II Acetabular Component System") . Osteolock NP and Osteolock Cluster Acetabular Shells (K971854 and K933102) . Citation TMZF HA Hip Stems (K993768) Device Description The subject Trident Acetabular Shells are characterized by the following features: . Shell substrate: Ti6A… | 2000 |
What descends from it? (150)
See all 1504 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 6 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K060437 (Aesculap, Inc., 2006) has gone furthest, with 90 descendants of its own.
- 9 other devices also cite its predicate K983382.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts. 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…
Read the full statement (100 words)
The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.
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 is 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/K001448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001448: Trident Acetabular Shells: PS-HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001448
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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