510(k) · Cleared
ClearedTrident Crossfire Polyuethylene Liners
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 Jul 2, 2002 after a 21-day review. The FDA summary names its predicate without a number. 54 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
54 later devices descend from it, 5 citing it directly.
- This deviceK021911 Trident Crossfire Polyuethylene LinersHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 23 of its ownK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
- Descendant · 2 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 3 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 3 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010 · cites it directly23descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 2 generations on21descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K122641Mpact ExtensionMedacta International · 2012 · 3 generations on14descendants
- K132879Mpact ExtensionMedacta International · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021911 | Trident Crossfire Polyuethylene Liners | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
| +2 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +3 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +3 | K132879 | Mpact Extension | Medacta International | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | — | Osteonics Secur-Fit AD Generation II Acetabular Component System Named without a submission number | |
| * | — | Line Extension, Osteonics Trident Polyethylene Inserts Named without a submission number | |
| * | — | Line Extension, Trident Elevated Rim Liners Named without a submission number |
What descends from it? (54)
See all 545 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | 2010 | 23 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K150007 | Modified Bencox Hip System | 2015 | 7 |
| K163441 | Locking Cage, Full XPE Cup | 2017 | 3 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained… | 2026 | 0 |
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?
- Of its descendants, K092265 (Medacta International S.A., 2010) has gone furthest, with 23 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 subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident series acetabular shells. (The predicate Trident series shells are intended for cementless fixation.) Indications: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. Revision of…
Read the full statement (106 words)
The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident series acetabular shells. (The predicate Trident series shells are intended for cementless fixation.)
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 failed 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 as stated in the FDA summary.
https://510kreport.com/device/K021911 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021911: Trident Crossfire Polyuethylene Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021911
Report an extraction error
Are you the manufacturer?
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