510(k) · Cleared
Recalled · Class II · 2017Bencox M Stem Lateralized & Bencox Mirabo Cup System
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 Dec 5, 2016 as substantially equivalent to K152084 (Corentec Co., Ltd., 2016) and 5 other predicates after a 126-day review. Its family tree reaches back 11 generations to 1981. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 11 generations to K810258 (1981). 198 ancestors in all, the oldest K791125 (1979). 6 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- 1 generation backK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- This deviceK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK220468 BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK223223 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 4 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- 1 generation backK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- This deviceK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · cites it directly4descendants
- K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · cites it directly3descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · cites it directly1descendant
- K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −4 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −3 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −2 | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| −1 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| 0 (this device) | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | — |
| +1 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +1 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
| +1 | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
| +1 | K220468 | BENCOX Mirabo Cup System | 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 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 22 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 12 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 17 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Summary page 5…persists e. Revision of previously failed total hip arthroplasty DEVICE DESCRIPTION 1) Bencox M Stem Lateralized: (Sterile) Similar to predicate device cleared under K152084, Bencox M Stem Lateralized is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When u… | 2016 |
| * | K010367 | Modification to Titanium Tri-Lock Hips StemSummary page 6…K152084 Lateralized Additional DePuy TriLock K010367 The Bencox M Stem Lateralized is a wedge shaped stem with porous coating intended for press fit application similar to t… | 2001 |
| * | K120924 | Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Summary page 5…f the following components: Acetabular Cup - Bencox Mirabo Cup Acetabular Liner - Bencox Mirabo PE Liner Hole Plugs – Dome hole (same as cleared in K120924 & K150007) Bone Screw - Bencox Bone Screw (same as cleared in K120924 & K150007) Acetabular Cup: Bencox Mirabo Cup… | 2012 |
| * | K150007 | Modified Bencox Hip SystemSummary page 5…owing components: Acetabular Cup - Bencox Mirabo Cup Acetabular Liner - Bencox Mirabo PE Liner Hole Plugs – Dome hole (same as cleared in K120924 & K150007) Bone Screw - Bencox Bone Screw (same as cleared in K120924 & K150007) Acetabular Cup: Bencox Mirabo Cup The Ben… | 2015 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 7…Bencox Mirabo PE Liner K150007 Pinnacle Acetabular System with K000306 & Additional DePuy ALTRX Liner K062148… | 2000 |
| * | K062148 | Depuy Pinnacle Altrx Acetabular Cup LinerSummary page 7…Pinnacle Acetabular System with K000306 & Additional DePuy ALTRX Liner K062148 The subject devices Bencox Mirabo Cup System and the Bencox Mirabo Cup System (K120924) has acetabular cups made of the… | 2006 |
What descends from it? (6)
6 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2017 | Class II | Z-1454-2017 | Other | Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 53 of the 197 ancestors have a recall of any class.
- Of its descendants, K172806 (Corentec Co., Ltd., 2017) has gone furthest, with 4 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. 2016, 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 M Stem Lateralized & Bencox Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or 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/K162127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162127: Bencox M Stem Lateralized & Bencox Mirabo 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/K162127
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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