510(k) · Cleared
ClearedTrident Screw Hole Plug and Trident Bone Spike
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 21, 2002 after a 90-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Nov 21, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK022799 Trident Screw Hole Plug and Trident Bone SpikeHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 1 of its ownK130353 Pipeline Total Hip System (Line Extension)Pipeline Orthopedics · 2013
- Descendant · 2 generations on · 0 of its ownK132626 Pipeline Total Hip System (Line Extension)Pipeline Biotechnology · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022799 | Trident Screw Hole Plug and Trident Bone Spike | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K130353 | Pipeline Total Hip System (Line Extension) | Pipeline Orthopedics | 2013 | — |
| +2 | K132626 | Pipeline Total Hip System (Line Extension) | Pipeline Biotechnology | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130353 | Pipeline Total Hip System (Line Extension) | 2013 | 1 |
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, K130353 (Pipeline Orthopedics, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Trident® Screw Hole Plugs are optional single-use devices that are intended to occlude the unused screw holes of the Trident® Porous Titanium Acetabular Component or the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating. The Trident® Screw Hole Plugs will be used either with or without bone cement depending upon the surgical application of the Trident® shell. More specifically, these Trident® Screw Holes Plugs have the…
Read the full statement (240 words)
The Trident® Screw Hole Plugs are optional single-use devices that are intended to occlude the unused screw holes of the Trident® Porous Titanium Acetabular Component or the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating. The Trident® Screw Hole Plugs will be used either with or without bone cement depending upon the surgical application of the Trident® shell.
More specifically, these Trident® Screw Holes Plugs have the following indications and contraindications:
Indications
In cemented or cementless hip arthroplasty, when a screw hole plug is thought to be advantageous
Contraindications
Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself.
The Trident® Bone Spikes are optional single-use devices that are intended to provide supplemental fixation of the Trident® Porous Titanium Acetabular Shell or the Trident® Porous Titanium Acetabular Shell with Peri-Apatite™ Coating in the prepared acetabulum in total hip arthroplasty. These Trident® Bone Spikes are intended to be used when the above-referenced Trident® acetabular shells are used in a press fit application.
More specifically, these Trident® Bone Spikes have the following indications and contraindications:
Trident® Bone Spikes are intended for supplemental fixation of the Trident® Porous Titanium Acetabular Shell and the Trident® Porous Titanium Acetabular Shell with Peri-Apatite Coating only.
Trident® Bone Spikes should be assembled to the Trident® acetabular shell prior to placement of the shell into the prepared acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022799: Trident Screw Hole Plug and Trident Bone Spike.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022799
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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