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 Feb 27, 2023 as substantially equivalent to K210614 (Corentec Co., Ltd., 2022) and 4 other predicates after a 133-day review. Its family tree reaches back 15 generations to 1981.
- Decided
- Feb 27, 2023
- Review
- 133 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K810258 (1981). 330 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations between
- 3 generations backK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- 2 generations backK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
- 1 generation backK220468 BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022
- This deviceK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 13 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 12 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 11 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 10 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 9 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 8 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 7 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 6 generations backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- 5 generations backK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- 4 generations backK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- 3 generations backK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- 2 generations backK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
- 1 generation backK220468 BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022
- This deviceK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −14 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −13 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −12 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −11 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −10 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −9 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −8 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −7 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −6 | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| −5 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| −4 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| −3 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| −2 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
| −1 | K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022 | — |
| 0 (this device) | 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 | 4 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 6 | 0 |
| 1993 | 8 | 0 |
| 1994 | 28 | 0 |
| 1995 | 18 | 0 |
| 1996 | 24 | 0 |
| 1997 | 17 | 0 |
| 1998 | 13 | 0 |
| 1999 | 14 | 0 |
| 2000 | 28 | 0 |
| 2001 | 18 | 0 |
| 2002 | 15 | 0 |
| 2003 | 11 | 0 |
| 2004 | 14 | 0 |
| 2005 | 14 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K210614 | BENCOX Mirabo Z Cup CortiniumSummary page 4…sthesis. (21CFR888.3358) Class: II Product Code(s): LPH Predicate Devices Primary predicate: BENCOX Mirabo Z cup Cortinium (K210614) Additional predicates: BENCOX Mirabo Cup System (K120924, K162127, K172806, K220468) Reason for 510(K) Submission The purpos… | 2022 |
| * | K120924 | Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Summary page 4…Product Code(s): LPH Predicate Devices Primary predicate: BENCOX Mirabo Z cup Cortinium (K210614) Additional predicates: BENCOX Mirabo Cup System (K120924, K162127, K172806, K220468) Reason for 510(K) Submission The purpose of this submission is to include an additional size 50mm d… | 2012 |
| * | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup SystemSummary page 4…Product Code(s): LPH Predicate Devices Primary predicate: BENCOX Mirabo Z cup Cortinium (K210614) Additional predicates: BENCOX Mirabo Cup System (K120924, K162127, K172806, K220468) Reason for 510(K) Submission The purpose of this submission is to include an additional size 50mm diameter a… | 2016 |
| * | K172806 | Bencox Mirabo Cup SystemSummary page 4…duct Code(s): LPH Predicate Devices Primary predicate: BENCOX Mirabo Z cup Cortinium (K210614) Additional predicates: BENCOX Mirabo Cup System (K120924, K162127, K172806, K220468) Reason for 510(K) Submission The purpose of this submission is to include an additional size 50mm diameter acetabular… | 2017 |
| * | K220468 | BENCOX Mirabo Cup SystemSummary page 4…(s): LPH Predicate Devices Primary predicate: BENCOX Mirabo Z cup Cortinium (K210614) Additional predicates: BENCOX Mirabo Cup System (K120924, K162127, K172806, K220468) Reason for 510(K) Submission The purpose of this submission is to include an additional size 50mm diameter acetabular cup to t… | 2022 |
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 42 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 86 of the 329 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?
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/K223223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223223: BENCOX Mirabo Z Cup Cortinium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223223
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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