510(k) · Cleared
ClearedBicontact Hip System with U-Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Dec 8, 2004 as substantially equivalent to K040191 (Aesculap, 2004) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1996. 166 later devices descend from it.
- Decided
- Dec 8, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K955033 (1996). 32 ancestors in all, the oldest K840643 (1984). 166 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 4 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 3 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 2 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 1 generation backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- This deviceK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · cites it directly · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · cites it directly · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 2 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
Showing 5 of 166 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 166 · See all- K093472Trinity Acetabular SystemCorin USA · 2010 · cites it directly117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · cites it directly90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 2 generations on68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −4 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −3 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −2 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −1 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| 0 (this device) | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +1 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +1 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 13 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 10 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 13 | 0 |
| 2026 | 12 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K040191 | Bicontact Hip Stem and Femoral HeadSummary page 2…P) Coating" was completed where applicable. SUBSTANTIAL EQUIVALENCE The Aesculap BiContact Hip System with u-CaP® is essentially identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111… | 2004 |
| * | K023102 | Accolade TMZF Plus HA 127 Size 0 Hip StemSummary page 2…SUBSTANTIAL EQUIVALENCE The Aesculap BiContact Hip System with u-CaP® is essentially identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111). DEPARTMENTOF HEALTH &… | 2002 |
| * | K020963 | Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral StemSummary page 2…ith u-CaP® is essentially identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111). DEPARTMENTOF HEALTH & HUMAN SERVICES Publ… | 2002 |
| * | K953111 | CorailSummary page 2…identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111). DEPARTMENTOF HEALTH & HUMAN SERVICES Public Health Service… | 1996 |
What descends from it? (166)
See all 1663 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 8 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 31 ancestors have a recall of any class.
- Of its descendants, K093472 (Corin USA, 2010) has gone furthest, with 117 descendants of its own.
- 7 other devices also cite its predicate K040191.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The BiContact Hip System with p-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.
The device is intended for:
* Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
* Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral eptiphysis
* Patients suffering from disability due to previous fusion
* Patients with acute femoral neck fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043079: Bicontact Hip System with U-Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043079
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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