510(k) · Cleared
ClearedExcia Total Hip System with U-Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Mar 22, 2006 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 2 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1996. 90 later devices descend from it.
- Decided
- Mar 22, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K955033 (1996). 68 ancestors in all, the oldest K840643 (1984). 90 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 4 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 3 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 2 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 1 generation backK043079 Bicontact Hip System with U-CapAesculap · 2004
- This deviceK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · cites it directly · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · cites it directly · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 63 of its ownK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- Descendant · 2 generations on · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- Descendant · 2 generations on · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · cites it directly83descendants
- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · cites it directly68descendants
- K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008 · 2 generations on63descendants
- K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · 2 generations on59descendants
- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −5 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −4 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −3 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −2 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −1 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| 0 (this device) | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +1 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +1 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +2 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| +2 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| +2 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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? (3)
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 |
|---|---|---|---|
| * | K042344 | Excia Total Hip SystemSummary page 2…oating" was completed where applicable. SUBSTANTIAL EQUIVALENCE The Aesculap Excia Total Hip System with p-CaP® is essentially identical to the Excia Total Hip System (K042344), BiContact Hip System with p-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448).… | 2005 |
| * | K043079 | Bicontact Hip System with U-CapSummary page 2…UBSTANTIAL EQUIVALENCE The Aesculap Excia Total Hip System with p-CaP® is essentially identical to the Excia Total Hip System (K042344), BiContact Hip System with p-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448). 7 DEPARTMENT… | 2004 |
| * | K001448 | Trident Acetabular Shells: PS-HASummary page 2…Hip System with p-CaP® is essentially identical to the Excia Total Hip System (K042344), BiContact Hip System with p-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448). 7 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2000 |
What descends from it? (90)
See all 905 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 10 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 20 of the 67 ancestors have a recall of any class.
- Of its descendants, K080584 (Aesculap Implant System, Inc., 2008) has gone furthest, with 83 descendants of its own.
- 16 other devices also cite its predicate K042344.
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 Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip 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 epiphysis Patients suffering from disability…
Read the full statement (112 words)
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
Patients suffering from severe hip 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 epiphysis
Patients suffering from disability due previous fusion
Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without p CaP®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060437: Excia Total Hip System with U-Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060437
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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