510(k) · Cleared
ClearedCoren Total 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 Jul 21, 2011 as substantially equivalent to K042249 (Zimmer Austin, Inc., 2004) and 5 other predicates after a 240-day review. Its family tree reaches back 6 generations to 1994. 11 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 240 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K941847 (1994). 55 ancestors in all, the oldest K840643 (1984). 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 4 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 3 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 2 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 1 generation backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- This deviceK103431 Coren Total Hip SystemCorentec Co., Ltd. · 2011
- Descendant · cites it directly · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · cites it directly · 8 of its ownK120924 Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes)…Corentec 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · cites it directly8descendants
- K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd. · 2012 · cites it directly8descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −4 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −3 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| 0 (this device) | K103431 | Coren Total Hip System | Corentec Co., Ltd. | 2011 | — |
| +1 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +1 | K120924 | Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo… | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 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 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 |
|---|---|---|---|
| * | K042249 | CLS Spotorno StemSummary page 2…vices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Zimmer Austin, Inc., CLSTM SpotomnoTM Stem, cleared under K042249; Sulzer Orthopedics, Inc., CLS Varus/CLS 135 Stem, cleared under K010839; Aesculap, Inc., Excia Total Hip System, c… | 2004 |
| * | K010839 | CLS Varus Stem/CLS 135 StemSummary page 2…o pre-amendment devices: Zimmer Austin, Inc., CLSTM SpotomnoTM Stem, cleared under K042249; Sulzer Orthopedics, Inc., CLS Varus/CLS 135 Stem, cleared under K010839; Aesculap, Inc., Excia Total Hip System, cleared under K042344; Wright Medical Technology, Inc., LINEAGE®V A-CLASS… | 2001 |
| * | K042344 | Excia Total Hip SystemSummary page 2…Stem, cleared under K042249; Sulzer Orthopedics, Inc., CLS Varus/CLS 135 Stem, cleared under K010839; Aesculap, Inc., Excia Total Hip System, cleared under K042344; Wright Medical Technology, Inc., LINEAGE®V A-CLASS TM Poly Liner, cleared under K052026; Biomet, Inc., Meta… | 2005 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 2…0839; Aesculap, Inc., Excia Total Hip System, cleared under K042344; Wright Medical Technology, Inc., LINEAGE®V A-CLASS TM Poly Liner, cleared under K052026; Biomet, Inc., Metal on Metal Acetabular System, cleared under K993438; and Biomet, Inc., M2aTM 32 mm Taper System,… | 2005 |
| * | K993438 | Metal on Metal Acetabular SystemSummary page 2…Wright Medical Technology, Inc., LINEAGE®V A-CLASS TM Poly Liner, cleared under K052026; Biomet, Inc., Metal on Metal Acetabular System, cleared under K993438; and Biomet, Inc., M2aTM 32 mm Taper System, cleared under K003363.… | 2000 |
| * | K003363 | M2A 32MM Taper SystemSummary page 2…ared under K052026; Biomet, Inc., Metal on Metal Acetabular System, cleared under K993438; and Biomet, Inc., M2aTM 32 mm Taper System, cleared under K003363. Page Algt3 510(k)… | 2000 |
What descends from it? (11)
See all 114 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 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 16 of the 54 ancestors have a recall of any class.
- Of its descendants, K121665 (Corentec Co., Ltd., 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K042249.
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. 2011, 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 COREN® Total Hip System is intended for 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103431: Coren Total 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/K103431
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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