510(k) · Cleared
ClearedExcia Total Hip System M an ML Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Sep 22, 2009 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 3 other predicates after a 69-day review. Its family tree reaches back 8 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 22, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K955033 (1996). 78 ancestors in all, the oldest K840643 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 7 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 6 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 5 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 4 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 3 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 2 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 1 generation backK061344 Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006
- This deviceK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK150062 Excia Total Hip SystemAesculap Implant Systems, LLC · 2015
- Descendant · cites it directly · 0 of its ownK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −7 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −6 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −5 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −4 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −3 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −1 | K061344 | Excia Total Hip System Lateral Offset | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K092143 | Excia Total Hip System M an ML Femoral Stem | Aesculap Implant Systems, Inc. | 2009 | — |
| +1 | K140915 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2014 | — |
| +2 | K150062 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2015 | — |
| +1 | K172235 | CoreHip® System | Aesculap Implants Systems, LLC | 2018 | — |
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 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K042344 | Excia Total Hip SystemSummary page 1…ZO, LWJ, MEH, KWY SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344). DEVICE DESCRIPTION The Excia M and ML femoral stem are available in one design. The femoral stem… | 2005 |
| * | K060437 | Excia Total Hip System with U-CapSummary page 1…MEH, KWY SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344). DEVICE DESCRIPTION The Excia M and ML femoral stem are available in one design. The femoral stem is manuf… | 2006 |
| * | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic HeadSummary page 1…SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344). DEVICE DESCRIPTION The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured f… | 2006 |
| * | K061344 | Excia Total Hip System Lateral OffsetSummary page 1…QUIVALENCE Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344). DEVICE DESCRIPTION The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a… | 2006 |
What descends from it? (3)
2 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 13 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 77 ancestors have a recall of any class.
- Of its descendants, K140915 (Aesculap Implant Systems, LLC, 2014) has gone furthest, with 2 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. 2009, this device’s year, is highlighted.
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 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 (116 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 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 V-CaP®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092143: Excia Total Hip System M an ML Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092143
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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