510(k) · Cleared
ClearedMetha Short Stem Hip System; Modular Hip System; Excia Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 7, 2008 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 5 other predicates after a 28-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 7, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K941847 (1994). 101 ancestors in all, the oldest K810258 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 6 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 5 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 3 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 2 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 1 generation backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- This deviceK081973 Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
- Descendant · cites it directly · 0 of its ownK110542 Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc. · 2011
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 |
|---|---|---|---|---|---|
| −8 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −6 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −5 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −2 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −1 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K081973 | Metha Short Stem Hip System; Modular Hip System; Excia Hip System | Aesculap Implant Systems, Inc. | 2008 | — |
| +1 | K172235 | CoreHip® System | Aesculap Implants Systems, LLC | 2018 | — |
| +1 | K110542 | Consensus Biolox Delta Ceramic Femoral Head | Consensus Orthopedics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 12 | 0 |
| 1995 | 10 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (6)
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…T CODE: LZO/ LPH SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Consensus Acetabular Cup is a line extension of Aesculap's Excia (K042344 - K062684) and Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Ac… | 2005 |
| * | K062684 | Excia Total Hip System 36MM Ceramic HeadSummary page 1…LZO/ LPH SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Consensus Acetabular Cup is a line extension of Aesculap's Excia (K042344 - K062684) and Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Acetabular C… | 2006 |
| * | K071916 | Metha Hip SystemSummary page 1…LZO/ LPH SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Consensus Acetabular Cup is a line extension of Aesculap's Excia (K042344 - K062684) and Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Acetabular Cup components have… | 2008 |
| * | K080584 | Metha Short Stem Hip SystemSummary page 1…H SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Consensus Acetabular Cup is a line extension of Aesculap's Excia (K042344 - K062684) and Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Acetabular Cup components have been clear… | 2008 |
| * | K020153 | Consensus Acetablar Shell, TI CoatedSummary page 1…2684) and Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Acetabular Cup components have been cleared in K020153 - K070061 for use with the Consensus and Unisyn hip systems from Hayes Medical. DEVICE DESCRIPTION The Consensus Acetabular… | 2002 |
| * | K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertSummary page 1…Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Acetabular Cup components have been cleared in K020153 - K070061 for use with the Consensus and Unisyn hip systems from Hayes Medical. DEVICE DESCRIPTION The Consensus Acetabular Cup from H… | 2007 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 26 of the 100 ancestors have a recall of any class.
- Of its descendants, K172235 (Aesculap Implants Systems, LLC, 2018) has gone furthest, with 0 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. 2008, 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 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 (295 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®.
The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
skeletally mature individuals undergoing primary surgery for total hip replacement
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
Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP:
A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
Acetabular components are indicated for cemented and cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081973: Metha Short Stem Hip System; Modular Hip System; Excia 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/K081973
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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