510(k) · Cleared
ClearedTriflange Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 23, 2000 as substantially equivalent to K952740 (Depuy, Inc., 1995) and 4 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1994. 213 later devices descend from it.
- Decided
- Jun 23, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K941847 (1994). 10 ancestors in all, the oldest K840643 (1984). 213 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 2 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 1 generation backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- This deviceK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
Showing 5 of 213 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 213 · See all- K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · cites it directly207descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 3 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −2 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −1 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| 0 (this device) | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +3 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +3 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 12 | 0 |
| 2012 | 16 | 0 |
| 2013 | 12 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 11 | 0 |
| 2025 | 19 | 0 |
| 2026 | 17 | 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? (5)
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 |
|---|---|---|---|
| * | K952740 | Depuy Duraloc 400 Acetabular CupSummary page 1…Hip Semi-Constrained, Uncemented, Metal/Polymer, Non-porous, Calcium- phosphate Substantially Equivalent Device: DePuy Duraloc® 400 Acetabular Cup.............cceoeee. K952740 DePuy Protrusio Cage......coveecveveceriiccniiiiinineiiiennens K962007 Biomet Patient Matched Flanged Acetabular Component ....… | 1995 |
| * | K962007 | Protrusion CagesSummary page 1…phosphate Substantially Equivalent Device: DePuy Duraloc® 400 Acetabular Cup.............cceoeee. K952740 DePuy Protrusio Cage......coveecveveceriiccniiiiinineiiiennens K962007 Biomet Patient Matched Flanged Acetabular Component ..........ccccceeiercverinccanns K983035 Sulzer Inter-Op™ HA Porous Acetabu… | 1996 |
| * | K983035 | Custom Flanged Acetabular ComponentSummary page 1…ee. K952740 DePuy Protrusio Cage......coveecveveceriiccniiiiinineiiiennens K962007 Biomet Patient Matched Flanged Acetabular Component ..........ccccceeiercverinccanns K983035 Sulzer Inter-Op™ HA Porous Acetabular SyStem .......occoveeeeieiiiiiieeieeenieens K972393 Zimmer Harris/Galante POrous........cc… | 1998 |
| * | K972393 | Inter-OP HA Porous Acetabular System (HA/Csti)Summary page 1…Patient Matched Flanged Acetabular Component ..........ccccceeiercverinccanns K983035 Sulzer Inter-Op™ HA Porous Acetabular SyStem .......occoveeeeieiiiiiieeieeenieens K972393 Zimmer Harris/Galante POrous........ccccocceevveeeiiiinnns K980711 Hip Prosthesis With HA/TCP Coating Device Description: The p… | 1997 |
| * | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingSummary page 1…verinccanns K983035 Sulzer Inter-Op™ HA Porous Acetabular SyStem .......occoveeeeieiiiiiieeieeenieens K972393 Zimmer Harris/Galante POrous........ccccocceevveeeiiiinnns K980711 Hip Prosthesis With HA/TCP Coating Device Description: The patient specific TriFlange™ Acetabular Cup System is an acetabular c… | 1998 |
What descends from it? (213)
See all 2133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K031495 (DePuy Orthopaedics, Inc., 2003) has gone furthest, with 207 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 TriFlange™ Acetabular Cup System is intended to be used with the Duraloc®
polyethylene liners to resurface the acetabular socket in cementless application during
total hip arthroplasty. The device is indicated for use in skeletally mature individuals
undergoing primary or revision surgery for rehabilitating hips damaged by disease,
deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or
any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis,
slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
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/K001277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001277: Triflange 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/K001277
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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