510(k) · Cleared
ClearedExcia Total Hip System 12/14 Trunnion with Ceramic Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 26, 2006 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 3 other predicates after a 52-day review. Its family tree reaches back 6 generations to 1994. 90 later devices descend from it.
- Decided
- May 26, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K941847 (1994). 55 ancestors in all, the oldest K840643 (1984). 90 later devices descend from it, 9 citing it directly.
- Root · 6 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 4 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 3 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 2 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 1 generation backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- This deviceK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · cites it directly · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · cites it directly · 65 of its ownK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- Descendant · cites it directly · 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 · 3 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
- K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006 · cites it directly65descendants
- K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008 · cites it directly63descendants
- K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · 2 generations on59descendants
- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · 3 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −4 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −3 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| 0 (this device) | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +1 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +1 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| +1 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| +2 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| +3 | 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 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 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 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 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 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? (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 SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the 12/14 Trunnion with Ceramic Head is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the BiContact Hip System (K040191), DePuy Ceramic Femoral Heads (K031803) and Alumina Ce… | 2005 |
| * | K040191 | Bicontact Hip Stem and Femoral HeadSummary page 1…n with Ceramic Head is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the BiContact Hip System (K040191), DePuy Ceramic Femoral Heads (K031803) and Alumina Ceramic Femoral Heads, 28 and 32 MM (K030724). DEVICE DESCRIPTION The Excia… | 2004 |
| * | K031803 | Depuy Ceramic Femoral HeadsSummary page 1…of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the BiContact Hip System (K040191), DePuy Ceramic Femoral Heads (K031803) and Alumina Ceramic Femoral Heads, 28 and 32 MM (K030724). DEVICE DESCRIPTION The Excia femoral component is available in two d… | 2003 |
| * | K030724 | Alumina Ceramic Femoral Heads, 28 and 32 MMSummary page 1…42344). It is also substantially equivalent to the BiContact Hip System (K040191), DePuy Ceramic Femoral Heads (K031803) and Alumina Ceramic Femoral Heads, 28 and 32 MM (K030724). DEVICE DESCRIPTION The Excia femoral component is available in two designs. One is manufactured from Ti with a plasma spray co… | 2003 |
What descends from it? (90)
See all 909 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080584 | Metha Short Stem Hip System | 2008 | 83 |
| K062684 | Excia Total Hip System 36MM Ceramic Head | 2006 | 65 |
| K082991 | Biolox Delta Ceramic Femoral Head | 2008 | 63 |
| K092143 | Excia Total Hip System M an ML Femoral Stem | 2009 | 3 |
| K140915 | Excia Total Hip System | 2014 | 2 |
| K150062 | Excia Total Hip System | 2015 | 1 |
| K121636 | Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert | 2012 | 1 |
| K090299 | Biolox Option Ceramic Femoral Head and Metha XL Heads | 2009 | 1 |
| K172235 | CoreHip® System | 2018 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 54 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 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.
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 and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 (110 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 necosis 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 CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Ti plasma spray.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060918 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060918
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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