510(k) · Cleared
Recalled · 2011Metha Hip System
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 Jun 2, 2008 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 4 other predicates after a 327-day review. Its family tree reaches back 7 generations to 1996. 68 later devices descend from it. It has been recalled once.
- Decided
- Jun 2, 2008
- Review
- 327 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K955033 (1996). 80 ancestors in all, the oldest K840643 (1984). 68 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 6 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 5 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 4 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 3 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 2 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 1 generation backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- This deviceK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008
- Descendant · cites it directly · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- Descendant · cites it directly · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 53 of its ownK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- Descendant · 2 generations on · 52 of its ownK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- Descendant · 3 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · cites it directly59descendants
- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · cites it directly58descendants
- K111193Apex Arc Hip StemOmni Life Science, Inc. · 2011 · 2 generations on53descendants
- K113242Apex Arc Hip StemOmni Life Science, Inc. · 2012 · 2 generations on52descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −6 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −5 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −4 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −3 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −2 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −1 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | — |
| +1 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| +1 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| +2 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| +2 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| +3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
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 |
| 1993 | 1 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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? (5)
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…, MEH, KWY SU.STANTMAL EQUIVALENCE Aesculap [mplant Systems, Inc. believes that the Metha® Hip System is substantially equivalent to: * Excia Total Hip System (K042344) * Excia Total Hip System with t-Ca_. (K060437) * Pro-Femur (K012091) · MAYO® Conservative Hip Prosthesis (K… | 2005 |
| * | K060437 | Excia Total Hip System with U-CapSummary page 1…Systems, Inc. believes that the Metha® Hip System is substantially equivalent to: * Excia Total Hip System (K042344) * Excia Total Hip System with t-Ca_. (K060437) * Pro-Femur (K012091) · MAYO® Conservative Hip Prosthesis (K030733) * Apex Modular HA Hip Stem (1<043123)… | 2006 |
| * | K012091 | Pro-FemurSummary page 1…he Metha® Hip System is substantially equivalent to: * Excia Total Hip System (K042344) * Excia Total Hip System with t-Ca_. (K060437) * Pro-Femur (K012091) · MAYO® Conservative Hip Prosthesis (K030733) * Apex Modular HA Hip Stem (1<043123) )EVCE ,pESCRPTON The MethaO)… | 2001 |
| * | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 SeriesSummary page 1…* Excia Total Hip System (K042344) * Excia Total Hip System with t-Ca_. (K060437) * Pro-Femur (K012091) · MAYO® Conservative Hip Prosthesis (K030733) * Apex Modular HA Hip Stem (1<043123) )EVCE ,pESCRPTON The MethaO) Hip System is a modular system which consists of two… | 2003 |
| * | K043123 | Apex Modular HA Hip StemSummary page 1…* Excia Total Hip System with t-Ca_. (K060437) * Pro-Femur (K012091) · MAYO® Conservative Hip Prosthesis (K030733) * Apex Modular HA Hip Stem (1<043123) )EVCE ,pESCRPTON The MethaO) Hip System is a modular system which consists of two components; the stem and the neck, Each comp… | 2005 |
What descends from it? (68)
See all 687 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083495 | Modification to: Metha Hip System | 2009 | 59 |
| K090845 | Apex Arc Hip Stem | 2010 | 58 |
| K102172 | Msa Hip System | 2011 | 3 |
| K112682 | Metha Hip System | 2012 | 2 |
| K081973 | Metha Short Stem Hip System; Modular Hip System; Excia Hip System | 2008 | 2 |
| K090299 | Biolox Option Ceramic Femoral Head and Metha XL Heads | 2009 | 1 |
| K102424 | Prevision Hip System with Recon Ring | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2011 | Not classified | Z-3014-2011 | Unknown/Undetermined by firm | Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 22 of the 79 ancestors have a recall of any class.
- Of its descendants, K083495 (Aesculap Implant Systems, Inc., 2009) has gone furthest, with 59 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. 2008, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071916: Metha Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071916
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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