510(k) · Cleared
ClearedTrident Acetabular Shells: PS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 4, 2000 as substantially equivalent to K983502 (Osteonics Corp., 1998) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1990. 69 later devices descend from it.
- Decided
- Aug 4, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K903362 (1990). 11 ancestors in all. 69 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
- 1 generation backK971854 Osteolock Acetabular Shell SystemHowmedica Corp. · 1997
- This deviceK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 68 of its ownK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
- Descendant · 2 generations on · 61 of its ownK081171 Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008
- Descendant · 2 generations on · 23 of its ownK040412 Trident T Acetabular ShellsStryker Orthopaedics · 2004
- Descendant · 3 generations on · 22 of its ownK101072 Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium…Howmedica Osteonics Corp. · 2011
- Descendant · 2 generations on · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · cites it directly68descendants
- K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008 · 2 generations on61descendants
- K040412Trident T Acetabular ShellsStryker Orthopaedics · 2004 · 2 generations on23descendants
- K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011 · 3 generations on22descendants
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903362 | Osteolock (TM) Acetabular Cup | Howmedica Corp. | 1990 | — |
| −1 | K971854 | Osteolock Acetabular Shell System | Howmedica Corp. | 1997 | — |
| 0 (this device) | K001449 | Trident Acetabular Shells: PS | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp. | 2001 | 8 |
| +2 | K081171 | Tritanium Acetabular Shell System | Howmedica Osteonics Corp. | 2008 | — |
| +2 | K040412 | Trident T Acetabular Shells | Stryker Orthopaedics | 2004 | — |
| +3 | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | Howmedica Osteonics Corp. | 2011 | — |
| +2 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 4 | 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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K983502 | Osteonics Secur-Fit AD Generation II Acetabular Component SystemSummary page 1…Uncemented Prosthesis 21 CFR §888.3353 Predicate Device Identification " Trident Acetabular Shells (K983502 - originally called the "Osteonics Secur=Fit AD Generation 11Acetabular Component System") " Osteol… | 1998 |
| * | K971854 | Osteolock Acetabular Shell SystemSummary page 1…nally called the "Osteonics Secur=Fit AD Generation 11Acetabular Component System") " Osteolock NP and Osteolock Cluster Acetabular Shells (K971854,,-and K933-1,02) " Partnership Revision Femoral Components (K972893) Device Description The subject Triden… | 1997 |
| * | K933102 | Howmedica Acetabular Shell W/Screw Holes | 1994 |
| * | K972893 | Partnership Revision Femoral StemsSummary page 1…nt System") " Osteolock NP and Osteolock Cluster Acetabular Shells (K971854,,-and K933-1,02) " Partnership Revision Femoral Components (K972893) Device Description The subject Trident Acetabular Shells are characterized by the following features: " Shell subst… | 1997 |
What descends from it? (69)
See all 691 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013676 | Trident Hemispherical Acetabular Shells | 2001 | 68 |
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 2 companies; a new generation was cleared every 6.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K013676 (Howmedica Osteonics Corp., 2001) has gone furthest, with 68 descendants of its own.
- 4 other devices also cite its predicate K983502.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The subject Trident Acetabular Shells are single-use devices intended for cemented or cementless fixation within the prepared acetabulurn. 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…
Read the full statement (100 words)
The subject Trident Acetabular Shells are single-use devices intended for cemented or cementless fixation within the prepared acetabulurn. 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.oxher 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 as stated in the FDA summary.
https://510kreport.com/device/K001449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001449: Trident Acetabular Shells: PS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001449
Report an extraction error
Are you the manufacturer?
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