510(k) · Cleared
ClearedDePuy 3D Additive TriFlange Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy International, Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 16, 2022 as substantially equivalent to K040383 (DePuy Orthopaedics, Inc., 2004) after a 756-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Jun 16, 2022
- Review
- 756 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930712 (1993). 20 ancestors in all, the oldest K840643 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 4 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 2 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 1 generation backK040383 Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2004
- This deviceK201348 DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232556 DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II…Depuy Ireland UC · 2023
Most influential descendants
Showing 1 of 1 · See all- K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −4 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −2 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K040383 | Triflange II Acetabular Cup System | DePuy Orthopaedics, Inc. | 2004 | — |
| 0 (this device) | K201348 | DePuy 3D Additive TriFlange Acetabular Cup | Depuy International, Ltd. | 2022 | — |
| +1 | K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular… | Depuy Ireland UC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K040383 | Triflange II Acetabular Cup SystemSummary page 4…Regulation 21 CFR 888.3358, 888.3353 Product Code(s) LPH, MEH Legally marketed DePuy TriFlange II Acetabular Cup System (K040383) device(s) to which equivalence is claimed Reason for 510(k) New manufacturing method – The subject devices are man… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | 2023 | 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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K232556 (Depuy Ireland UC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040383.
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. 2022, this device’s year, is highlighted.
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 TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
The TriFlange Hip Prosthesis is indicated in the following conditions:
1. Where bone loss is present in the acetabular region
2. Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
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/K201348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201348: DePuy 3D Additive TriFlange Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201348
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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