510(k) · Cleared
ClearedModified Bencox Hip 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 May 4, 2015 as substantially equivalent to K120924 (Corentec Co., Ltd., 2012) and 8 other predicates after a 122-day review. Its family tree reaches back 10 generations to 1981. 7 later devices descend from it.
- Decided
- May 4, 2015
- Review
- 122 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 10 generations to K810258 (1981). 137 ancestors in all, the oldest K800207 (1980). 7 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 1 generation backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- This deviceK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · cites it directly · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
- Descendant · 2 generations on · 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
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 1 generation backK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- This deviceK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · cites it directly6descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · cites it directly4descendants
- K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · 2 generations on3descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · 2 generations on1descendant
- K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −3 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −2 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −1 | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| 0 (this device) | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +1 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +1 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +2 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
| +2 | K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022 | — |
| +1 | K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 17 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (9)
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 5…oplasty [The intended use of the modified devices of modified Bencox Hip System has not changed as a result of the modification of the predicate devices, cleared under, K120924 (K103431), K112019 & K121665] DEVICE DESCRIPTION The Modified Bencox Mirabo Hip System consists of the following compone… | 2012 |
| * | K103431 | Coren Total Hip SystemSummary page 5…[The intended use of the modified devices of modified Bencox Hip System has not changed as a result of the modification of the predicate devices, cleared under, K120924 (K103431), K112019 & K121665] DEVICE DESCRIPTION The Modified Bencox Mirabo Hip System consists of the following components, x… | 2011 |
| * | K974685 | Osteonics Polyethylene Acetabular ComponentsSummary page 6…tal Hip System K103431 Osteonics (Crossfire) PE Acetabular Osteonics / Howmedica K974685 & Components & Trident Acetabular Osteonics Corp.… | 1998 |
| * | K021911 | Trident Crossfire Polyuethylene LinersSummary page 6…K974685 & Components & Trident Acetabular Osteonics Corp. K021911 System Bencox ID Stem (Offset) Corentec Co. Ltd… | 2002 |
| * | K112019 | Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupSummary page 5…ded use of the modified devices of modified Bencox Hip System has not changed as a result of the modification of the predicate devices, cleared under, K120924 (K103431), K112019 & K121665] DEVICE DESCRIPTION The Modified Bencox Mirabo Hip System consists of the following components, x Acetabula… | 2011 |
| * | K043537 | Taperloc 12/14 Taper Femoral ComponentsSummary page 6…D Stem (Offset) Corentec Co. Ltd. Bencox ID Stem K112019 Biomet Taperloc K043537 Bencox Delta Heads XL Corentec Co., Ltd. Bencox Forte & Bencox Delta K1… | 2005 |
| * | K121665 | Bencox Foret & Bencox DeltaSummary page 5…the modified devices of modified Bencox Hip System has not changed as a result of the modification of the predicate devices, cleared under, K120924 (K103431), K112019 & K121665] DEVICE DESCRIPTION The Modified Bencox Mirabo Hip System consists of the following components, x Acetabular Insert -… | 2012 |
| * | K112115 | Mectacer Biolox (R) Delta Femoral HeadsSummary page 6…Corentec Co., Ltd. Bencox Forte & Bencox Delta K121665 MEDACTA MectaCer Biolox Delta Heads K112115 International SA Zimmer, Inc Biolox delta Ceramic Femoral Head K071535 PERFORMANCE DATA… | 2011 |
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 6…MectaCer Biolox Delta Heads K112115 International SA Zimmer, Inc Biolox delta Ceramic Femoral Head K071535 PERFORMANCE DATA Performance testing for modified Bencox Mirabo PE Insert was carried out to demonstrate substantial e… | 2007 |
What descends from it? (7)
3 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?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 34 of the 136 ancestors have a recall of any class.
- Of its descendants, K162127 (Corentec Co., Ltd., 2016) has gone furthest, with 6 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. 2015, 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?
The Modified Bencox Hip System is intended for use in total or partial 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/K150007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150007: Modified Bencox Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150007
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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