510(k) · Cleared
Recalled · 2007Excia Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Mar 16, 2005 as substantially equivalent to K040191 (Aesculap, 2004) and 6 other predicates after a 198-day review. Its family tree reaches back 5 generations to 1994. 198 later devices descend from it. It has been recalled 10 times.
- Decided
- Mar 16, 2005
- Review
- 198 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- 10
- Predicates
- 7
Its longest line of descent runs back 5 generations to K941847 (1994). 49 ancestors in all, the oldest K840643 (1984). 198 later devices descend from it, 17 citing it directly.
- Root · 5 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 4 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 3 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 2 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 1 generation backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- This deviceK042344 Excia Total Hip SystemAesculap, Inc. · 2005
- Descendant · cites it directly · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · cites it directly · 90 of its ownK060437 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 · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- Descendant · 2 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
Showing 5 of 198 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 198 · See all- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · cites it directly90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · cites it directly90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · cites it directly83descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · cites it directly79descendants
- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 2 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −4 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −3 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −2 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | — |
| +1 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +1 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +1 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +1 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| +2 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
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 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 15 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 13 | 0 |
| 2023 | 14 | 0 |
| 2024 | 9 | 0 |
| 2025 | 19 | 0 |
| 2026 | 16 | 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (7)
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…pplicable. SUBSTANTIAL EQUIVALENCE Aesculap believes that the new Excia Total Hip System is substantially equivalent in design to: * BiCONTACT Hip System (K040191) * 36mm V40 Femoral Head Components (K022077) · Alloclassic Zweymueller (K030373) · SC… | 2004 |
| * | K022077 | 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Summary page 2…the new Excia Total Hip System is substantially equivalent in design to: * BiCONTACT Hip System (K040191) * 36mm V40 Femoral Head Components (K022077) · Alloclassic Zweymueller (K030373) · SC Total Hip System (K031474) * Smith & Nephew H… | 2002 |
| * | K030373 | Alloclassic Zweymueller SL/SLL Femoral StemSummary page 2…uivalent in design to: * BiCONTACT Hip System (K040191) * 36mm V40 Femoral Head Components (K022077) · Alloclassic Zweymueller (K030373) · SC Total Hip System (K031474) * Smith & Nephew Hip System (K022902) * Pinnacle Duofi… | 2003 |
| * | K031474 | SC Total Hip SystemSummary page 2…CT Hip System (K040191) * 36mm V40 Femoral Head Components (K022077) · Alloclassic Zweymueller (K030373) · SC Total Hip System (K031474) * Smith & Nephew Hip System (K022902) * Pinnacle Duofix HA Acetabular Cup (K031495)… | 2003 |
| * | K022902 | Smith & Nephew Hip SystemSummary page 2…oral Head Components (K022077) · Alloclassic Zweymueller (K030373) · SC Total Hip System (K031474) * Smith & Nephew Hip System (K022902) * Pinnacle Duofix HA Acetabular Cup (K031495) Trident Porous Ti Acetabular Component with Coating… | 2002 |
| * | K031495 | Pinnacle Duofix HA Acetabular Cup ProsthesisSummary page 2…weymueller (K030373) · SC Total Hip System (K031474) * Smith & Nephew Hip System (K022902) * Pinnacle Duofix HA Acetabular Cup (K031495) Trident Porous Ti Acetabular Component with Coating (K01 3475) i DEPARTMENT OF HEALTH & H… | 2003 |
| * | K013475 | Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingSummary page 2…* Smith & Nephew Hip System (K022902) * Pinnacle Duofix HA Acetabular Cup (K031495) Trident Porous Ti Acetabular Component with Coating (K01 3475) i DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2001 |
What descends from it? (198)
See all 19817 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | 2006 | 90 |
| K060437 | Excia Total Hip System with U-Cap | 2006 | 90 |
| K080584 | Metha Short Stem Hip System | 2008 | 83 |
| K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | 2007 | 79 |
| K071916 | Metha Hip System | 2008 | 68 |
| K062684 | Excia Total Hip System 36MM Ceramic Head | 2006 | 65 |
| K082991 | Biolox Delta Ceramic Femoral Head | 2008 | 63 |
| K103431 | Coren Total Hip System | 2011 | 11 |
| K060707 | Aesculap Bipolar Acetabular Cup | 2006 | 11 |
| K163577 | Ecofit® Hip System | 2017 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2007 | Not classified | Z-0436-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0438-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0437-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0439-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0442-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0443-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0444-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0440-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0441-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Oct 10, 2007 | Not classified | Z-0445-2008 | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 14 of the 48 ancestors have a recall of any class.
- Of its descendants, K060918 (Aesculap, Inc., 2006) has gone furthest, with 90 descendants of its own.
- 7 other devices also cite its predicate K040191.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
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 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 epiphysis Patients suffering from…
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 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 epiphysis
Patients suffering from disability due to previous fusion
Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042344: Excia Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042344
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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