510(k) · Cleared
ClearedExcia Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 21, 2014 as substantially equivalent to K092143 (Aesculap Implant Systems, Inc., 2009) and 1 other predicate after a 102-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 21, 2014
- Review
- 102 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K955033 (1996). 79 ancestors in all, the oldest K840643 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations between
- 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 2 generations backK061344 Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006
- 1 generation backK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
- This deviceK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
- Descendant · cites it directly · 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
Show all 9 generations
- Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 8 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 7 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 6 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 5 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 4 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 2 generations backK061344 Excia Total Hip System Lateral OffsetAesculap, Inc. · 2006
- 1 generation backK092143 Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009
- This deviceK140915 Excia Total Hip SystemAesculap Implant Systems, LLC · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −8 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −7 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −6 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −5 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −4 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −2 | K061344 | Excia Total Hip System Lateral Offset | Aesculap, Inc. | 2006 | — |
| −1 | K092143 | Excia Total Hip System M an ML Femoral Stem | Aesculap Implant Systems, Inc. | 2009 | — |
| 0 (this device) | K140915 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2014 | — |
| +1 | 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 |
|---|---|---|
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K092143 | Excia Total Hip System M an ML Femoral StemSummary page 1…LLC believes that the addition of Excia T femoral stems to Excia Total Hip System is substantially equivalent to Aesculap Implant Systems Excia Total Hip System (510(K)s K092143 and K060918) and Smith & Nephew Synergy Hip System.… | 2009 |
| * | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic HeadSummary page 1…that the addition of Excia T femoral stems to Excia Total Hip System is substantially equivalent to Aesculap Implant Systems Excia Total Hip System (510(K)s K092143 and K060918) and Smith & Nephew Synergy Hip System.… | 2006 |
| * | — | Smith & Nephew Synergy Hip System Named without a submission number |
What descends from it? (2)
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 18 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 78 ancestors have a recall of any class.
- Of its descendants, K150062 (Aesculap Implant Systems, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K092143.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 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 ephiphysis - Patients suffering from…
Read the full statement (117 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 ephiphysis
- Patients suffering from disability due to previous fusion
- Patients with acute femoral neck fractures
The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without pCaP®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140915: Excia 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/K140915
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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