510(k) · Cleared
ClearedDePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Sep 20, 2023 as substantially equivalent to K201348 (Depuy International, Ltd., 2022) and 1 other predicate after a 28-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Sep 20, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930712 (1993). 21 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 4 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 3 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 2 generations backK040383 Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2004
- 1 generation backK201348 DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd. · 2022
- This deviceK232556 DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II…Depuy Ireland UC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −5 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −4 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −3 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K040383 | Triflange II Acetabular Cup System | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K201348 | DePuy 3D Additive TriFlange Acetabular Cup | Depuy International, Ltd. | 2022 | — |
| 0 (this device) | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K201348 | DePuy 3D Additive TriFlange Acetabular CupSummary page 5…Regulation 21 CFR 888.3358, 888.3353 Product Code(s) LPH, MEH Legally marketed device(s) DePuy 3D Additive TriFlange Acetabular Cup (K201348) to which equivalence is DePuy TriFlange II Acetabular Cup System (K040383) (Primary Predicate) claimed… | 2022 |
| * | K040383 | Triflange II Acetabular Cup SystemSummary page 5…LPH, MEH Legally marketed device(s) DePuy 3D Additive TriFlange Acetabular Cup (K201348) to which equivalence is DePuy TriFlange II Acetabular Cup System (K040383) (Primary Predicate) claimed… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 20 ancestors have a recall of any class.
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. 2023, 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 bones loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications. The system is intended to be used with modular liners to…
Read the full statement (190 words)
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 bones loss is present in the acetabular region
2. Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Porous-coated TriFlange Hip Prostheses are indicated for cement-less 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/K232556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232556: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232556
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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