510(k) · Cleared
ClearedMetha Short Stem Hip System XL Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Sep 9, 2008 as substantially equivalent to K080584 (Aesculap Implant System, Inc., 2008) and 1 other predicate after a 41-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Sep 9, 2008
- Review
- 41 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K955033 (1996). 76 ancestors in all, the oldest K840643 (1984). 2 later devices descend from it, 1 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 backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- This deviceK082146 Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK090299 Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems · 2009
- Descendant · 2 generations on · 0 of its ownK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
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 | 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 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| 0 (this device) | K082146 | Metha Short Stem Hip System XL Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| +1 | K090299 | Biolox Option Ceramic Femoral Head and Metha XL Heads | Aesculap Implant Systems | 2009 | — |
| +2 | 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 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 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 |
|---|---|---|
| 2009 | 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 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? (2)
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 |
|---|---|---|---|
| * | K080584 | Metha Short Stem Hip System | 2008 |
| * | K040191 | Bicontact Hip Stem and Femoral HeadSummary page 1…esculap Implant Systems, Inc. Metha& Short Stem Hip System that was cleared (KO80584). It is also substantially equivalent to the BiContact Hip System and Femoral Head (K0401 91). DEVICE DESCRIPTION The Metha®D Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The X… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090299 | Biolox Option Ceramic Femoral Head and Metha XL Heads | 2009 | 1 |
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 7 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 75 ancestors have a recall of any class.
- Of its descendants, K090299 (Aesculap Implant Systems, 2009) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K080584.
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. 2008, this device’s year, is highlighted.
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 Metha® Short Stem 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 as stated in the FDA summary.
https://510kreport.com/device/K082146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082146: Metha Short Stem Hip System XL Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082146
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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