510(k) · Cleared
ClearedBencox Foret & Bencox Delta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 25, 2012 as substantially equivalent to K073337 (Medacta International S.A., 2008) and 3 other predicates after a 111-day review. Its family tree reaches back 7 generations to 1994. 8 later devices descend from it.
- Decided
- Sep 25, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K941847 (1994). 101 ancestors in all, the oldest K800207 (1980). 8 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 5 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 4 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 2 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 1 generation backK103431 Coren Total Hip SystemCorentec Co., Ltd. · 2011
- This deviceK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · cites it directly · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 2 generations on · 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 · 3 generations on · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · cites it directly7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 2 generations on4descendants
- K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · 3 generations on3descendants
- K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −5 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −4 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −1 | K103431 | Coren Total Hip System | Corentec Co., Ltd. | 2011 | — |
| 0 (this device) | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +1 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +2 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +2 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +3 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
| +3 | K210614 | BENCOX Mirabo Z Cup Cortinium | 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 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 12 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K073337 | Mectacer Biolox Forte-Femoral HeadsSummary page 2…evices, each of which has been determined by FDA to be substantially equivalent: * MEDACTA International SA; MectaCer BIOLOX forte Femoral Heads cleared under K073337, * DePuy Orthopedics, Inc., DePuy Delta Ceramic Femoral Head cleared under K(062748, * Corentec Co., Ltd., Coren To… | 2008 |
| * | K062748 | Modification: to Depuy Delta Ceramic Femoral HeadSummary page 2…International SA; MectaCer BIOLOX forte Femoral Heads cleared under K073337, * DePuy Orthopedics, Inc., DePuy Delta Ceramic Femoral Head cleared under K(062748, * Corentec Co., Ltd., Coren Total Hip System & Bencox Bipolar Cup System cleared under K 103431 & K 11201 9 (FemioralH… | 2006 |
| * | K103431 | Coren Total Hip SystemSummary page 2…cs, Inc., DePuy Delta Ceramic Femoral Head cleared under K(062748, * Corentec Co., Ltd., Coren Total Hip System & Bencox Bipolar Cup System cleared under K 103431 & K 11201 9 (FemioralHeads). PERFORMANCE TESTING Performance testing of the Bencox Forte/Delta Femoral Heads was conduc… | 2011 |
| * | K112019 | Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupSummary page 2…ePuy Delta Ceramic Femoral Head cleared under K(062748, * Corentec Co., Ltd., Coren Total Hip System & Bencox Bipolar Cup System cleared under K 103431 & K 11201 9 (FemioralHeads). PERFORMANCE TESTING Performance testing of the Bencox Forte/Delta Femoral Heads was conducted in accor… | 2011 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150007 | Modified Bencox Hip System | 2015 | 7 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 23 of the 100 ancestors have a recall of any class.
- Of its descendants, K150007 (Corentec Co., Ltd., 2015) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K073337.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Bencox Forte and Bencox Delta ceramic heads are 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 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 hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121665: Bencox Foret & Bencox Delta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121665
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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