510(k) · Cleared
ClearedCustom Flanged Acetabular Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 23, 1998 after an 84-day review. The FDA summary names its predicate without a number. 219 later devices descend from it.
- Decided
- Nov 23, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
219 later devices descend from it, 4 citing it directly.
- This deviceK983035 Custom Flanged Acetabular ComponentBiomet, Inc. · 1998
- Descendant · cites it directly · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 4 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
Showing 5 of 219 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 219 · See all- K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly213descendants
- K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 2 generations on207descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 4 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 4 generations on90descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983035 | Custom Flanged Acetabular Component | Biomet, Inc. | 1998 | — |
| +1 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| +3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +4 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +4 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 12 | 0 |
| 2012 | 16 | 0 |
| 2013 | 13 | 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 | 15 | 0 |
| 2023 | 17 | 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? (4)
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 |
|---|---|---|---|
| * | — | Healey™ Revision Acetabular Component Named without a submission number | |
| * | — | Recovery Protusio Cage Named without a submission number | |
| * | — | Universal® Acetabular Component Named without a submission number | |
| * | — | Mallory-Head® Acetabular Component Named without a submission number |
What descends from it? (219)
See all 2194 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?
- Of its descendants, K001277 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 213 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 Patient Matched Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for either cemented or cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with Biomet's RingLoc® Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.
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/K983035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983035: Custom Flanged Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983035
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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