510(k) · Cleared
ClearedEPORE® XO cup system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Cleared on Apr 24, 2026 as substantially equivalent to K180263 (Implantcast GmbH, 2018) and 2 other predicates after a 263-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Apr 24, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- OQI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K931641 (1994). 305 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- 2 generations backK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- 1 generation backK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- This deviceK252451 EPORE® XO cup systemImplantcast GmbH · 2026
Show all 14 generations
- Root · 14 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 12 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 11 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 10 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 9 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 8 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 7 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 6 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 5 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 4 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 3 generations backK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- 2 generations backK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- 1 generation backK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- This deviceK252451 EPORE® XO cup systemImplantcast GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −12 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −11 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −10 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −9 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −8 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −7 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −6 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −5 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| −4 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| −3 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| −2 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| −1 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| 0 (this device) | K252451 | EPORE® XO cup system | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 4 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 30 | 0 |
| 1995 | 22 | 0 |
| 1996 | 26 | 0 |
| 1997 | 15 | 0 |
| 1998 | 14 | 0 |
| 1999 | 14 | 0 |
| 2000 | 27 | 0 |
| 2001 | 10 | 0 |
| 2002 | 13 | 0 |
| 2003 | 13 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 OQI? 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 OQI device
- #1 K192989 Libertas E-XLPE Modular Linerscore 4.2 · 14 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K180263 | EcoFit Vit E Acetabular SystemSummary page 5…additive, porous uncemented Device Class: Class II Product Codes: OQI, OQG Primary Predicate: EcoFit® Hip System (K180263/ K203420/ K163577) Reference Device: G7® Acetabular System (K190660) Device Description: The subject EPORE® XO cup sys… | 2018 |
| * | K203420 | EcoFit® Hip SystemSummary page 5…additive, porous uncemented Device Class: Class II Product Codes: OQI, OQG Primary Predicate: EcoFit® Hip System (K180263/ K203420/ K163577) Reference Device: G7® Acetabular System (K190660) Device Description: The subject EPORE® XO cup system inclu… | 2021 |
| * | K163577 | Ecofit® Hip SystemSummary page 5…additive, porous uncemented Device Class: Class II Product Codes: OQI, OQG Primary Predicate: EcoFit® Hip System (K180263/ K203420/ K163577) Reference Device: G7® Acetabular System (K190660) Device Description: The subject EPORE® XO cup system includes addit… | 2017 |
| † | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System… | 2019 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 61 of the 304 ancestors have a recall of any class.
- 4 other devices also cite its predicate K180263.
How does its category compare?
All OQI devicesOQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OQI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OQI
Too few OQI 510(k)s in any year since 2007 to give a median.
Recalls per year · OQI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQI
45in 2025
MAUDE reports naming product code OQI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 0 | — | 1 | 23 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EPORE® XO cup system is intended for hip joint arthroplasty in cases of:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
• Revision of previously failed hip arthroplasty.
The EPORE® XO acetabular cups are intended for uncemented biological fixation.
The EPORE® XO cup system acetabular cups and cup inserts are intended to be used with mating femoral heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252451: EPORE® XO 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/K252451
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026