510(k) · Cleared
Recalled · Class II · 2019Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
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 Apr 29, 2016 as substantially equivalent to K010367 (DePuy Orthopaedics, Inc., 2001) and 10 other predicates after a 277-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 29, 2016
- Review
- 277 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 11
Its longest line of descent runs back 6 generations to K935452 (1994). 69 ancestors in all, the oldest K791125 (1979). 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 1 generation backK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- This deviceK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016
- Descendant · cites it directly · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK220468 BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022
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 · 2 generations on4descendants
- 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 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −5 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −3 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| 0 (this device) | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with… | Corentec Co., Ltd. | 2016 | — |
| +1 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +2 | 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 | — |
| +2 | K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 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? (11)
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 |
|---|---|---|---|
| * | K010367 | Modification to Titanium Tri-Lock Hips StemSummary page 7…Manufacturer Trade Name 510(k) Category Primary DePuy TriLock K010367 BENCOX M STEM K103479 & Additional… | 2001 |
| * | K103479 | Novel Tapered Hip StemSummary page 7…Primary DePuy TriLock K010367 BENCOX M STEM K103479 & Additional Stryker Allocade II… | 2011 |
| * | K120578 | Accolade II Hip StemSummary page 7…K103479 & Additional Stryker Allocade II K120578 K803126;… | 2012 |
| * | K803126 | Exeter Total Hip SystemSummary page 7…K120578 K803126; Exeter/Exeter V40 Stem BENCOX Stryker… | 1981 |
| * | K011623 | Exeter Hip System with V40 TaperSummary page 7…K803126; Exeter/Exeter V40 Stem BENCOX Stryker K011623; K110290 Primary ID (Howmedica)… | 2001 |
| * | K110290 | Exeter Hip StemSummary page 7…803126; Exeter/Exeter V40 Stem BENCOX Stryker K011623; K110290 Primary ID (Howmedica) Exeter D… | 2011 |
| * | K974054 | Distal Centralizer, Exeter II Hip SystemSummary page 7…K011623; K110290 Primary ID (Howmedica) Exeter Distal Centralizer K974054 Cemented STEM (with C Stem AMT Stem K042959 Centralizer) Additional… | 1997 |
| * | K042959 | Depuy C-Stem Amt Hip ProsthesisSummary page 7…Exeter Distal Centralizer K974054 Cemented STEM (with C Stem AMT Stem K042959 Centralizer) Additional DePuy C Stem AMT Distal K042959 &… | 2004 |
| * | K013350 | Modification to Depuy C-Stem SystemSummary page 7…alizer) Additional DePuy C Stem AMT Distal K042959 & Centralizer K013350 Smith & K791125 (Referred BENCOX Primary… | 2001 |
| * | K791125 | Plug-Lok Cement RestirctorSummary page 7…Centralizer K013350 Smith & K791125 (Referred BENCOX Primary Buck Cement Restrictor Nephew… | 1979 |
| * | K001733 | Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…Summary page 7…Nephew in K023680) BONE PLUG Additional Zimmer Allen Medullary Bone Plug K001733 As described in the Device Description section, the technological characteristics, such as design, material, indications, and… | 2000 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | 2016 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2019 | Class II | Z-0496-2020 | Under Investigation by firm | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 24 of the 69 ancestors have a recall of any class.
- Of its descendants, K162127 (Corentec Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K010367.
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 (Bencox 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…
Read the full statement (229 words)
Bencox M Stem (Bencox 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
The Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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 trochanteric 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
The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.
The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152084
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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