510(k) · Cleared
ClearedBENCOX Mirabo Z Cup Cortinium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 24, 2022 as substantially equivalent to K120924 (Corentec Co., Ltd., 2012) and 9 other predicates after a 449-day review. Its family tree reaches back 14 generations to 1981. 1 later device descends from it.
- Decided
- May 24, 2022
- Review
- 449 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 14 generations to K810258 (1981). 288 ancestors in all, the oldest K791125 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations between
- 3 generations backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- 2 generations backK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · Recalled
- 1 generation backK182502 Alteon Acetabular Cup SystemExactech, Inc. · 2019 · Recalled
- This deviceK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 3 generations backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- 2 generations backK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · Recalled
- 1 generation backK182502 Alteon Acetabular Cup SystemExactech, Inc. · 2019 · Recalled
- This deviceK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −13 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −12 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −11 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −10 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −9 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −8 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −7 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −6 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −5 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −3 | K111481 | Corin Trinity Acetabular System Ecima Liners | Corin USA | 2012 | 1 |
| −2 | K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | 2018 | 3 |
| −1 | K182502 | Alteon Acetabular Cup System | Exactech, Inc. | 2019 | 2 |
| 0 (this device) | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
| +1 | K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 26 | 0 |
| 1995 | 16 | 0 |
| 1996 | 21 | 0 |
| 1997 | 13 | 0 |
| 1998 | 12 | 0 |
| 1999 | 12 | 0 |
| 2000 | 27 | 0 |
| 2001 | 16 | 0 |
| 2002 | 13 | 0 |
| 2003 | 11 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (10)
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 |
|---|---|---|---|
| * | K120924 | Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Summary page 4…eted Predicate Devices to Which Substantial Equivalence is Claimed: Primary predicate: 510(k) Number Trade or Proprietary Model Name Manufacturer K120924 BENCOX Mirabo Cup System Corentec Co.,Ltd. Additional Predicates Supporting Substantial Equiv… | 2012 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 4…Corentec Co.,Ltd. Additional Predicates Supporting Substantial Equivalence: 510(k) Number Trade or Proprietary Model Name Manufacturer K000306 & Pinnacle Acetabular System with ALTRX Liner DePuy Orthopaedics, K093646… | 2000 |
| * | K093646 | Depuy Pinnacle with Gription Acetabular CupsSummary page 4…Number Trade or Proprietary Model Name Manufacturer K000306 & Pinnacle Acetabular System with ALTRX Liner DePuy Orthopaedics, K093646 Inc. K150790 REDAPT Porous Acetabular Shell and Cemen… | 2009 |
| * | K150790 | REDAPT Porous Acetabular Shell and Cemented LinerSummary page 4…K000306 & Pinnacle Acetabular System with ALTRX Liner DePuy Orthopaedics, K093646 Inc. K150790 REDAPT Porous Acetabular Shell and Cemented Smith & Nephew Inc. Liner K061253, K070756… | 2015 |
| * | K061253 | Reflection 3 Acetabular SystemSummary page 4…Inc. K150790 REDAPT Porous Acetabular Shell and Cemented Smith & Nephew Inc. Liner K061253, K070756 REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew Inc. K182502 Exactech® Alteon® Acetabu… | 2006 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 4…Inc. K150790 REDAPT Porous Acetabular Shell and Cemented Smith & Nephew Inc. Liner K061253, K070756 REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew Inc. K182502 Exactech® Alteon® Acetabular Cup S… | 2007 |
| * | K182502 | Alteon Acetabular Cup SystemSummary page 4…lar Shell and Cemented Smith & Nephew Inc. Liner K061253, K070756 REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew Inc. K182502 Exactech® Alteon® Acetabular Cup System Exactech, Inc. K162127 BENCOX Mirabo Cup Line extensi… | 2019 |
| * | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup SystemSummary page 4…K070756 REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew Inc. K182502 Exactech® Alteon® Acetabular Cup System Exactech, Inc. K162127 BENCOX Mirabo Cup Line extension Corentec Co.,Ltd. K172806 BENCOX Mirabo Cup Line exte… | 2016 |
| * | K172806 | Bencox Mirabo Cup SystemSummary page 4…Exactech® Alteon® Acetabular Cup System Exactech, Inc. K162127 BENCOX Mirabo Cup Line extension Corentec Co.,Ltd. K172806 BENCOX Mirabo Cup Line extension Corentec Co.,Ltd. K182221 BENCOX Mirabo Cup Multi hol… | 2017 |
| * | K182221 | Bencox Mirabo Cup Multi HoleSummary page 4…BENCOX Mirabo Cup Line extension Corentec Co.,Ltd. K172806 BENCOX Mirabo Cup Line extension Corentec Co.,Ltd. K182221 BENCOX Mirabo Cup Multi hole Corentec Co.,Ltd.… | 2019 |
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 |
|---|---|---|---|
| K223223 | BENCOX Mirabo Z Cup Cortinium | 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 41 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 78 of the 287 ancestors have a recall of any class.
- Of its descendants, K223223 (Corentec Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K120924.
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?
BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for cementless use in total hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture, and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210614: BENCOX Mirabo Z Cup Cortinium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210614
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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