510(k) · Cleared
ClearedMetha 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 Mar 19, 2012 as substantially equivalent to K080584 (Aesculap Implant System, Inc., 2008) and 4 other predicates after a 186-day review. Its family tree reaches back 8 generations to 1996. 1 of the 92 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 19, 2012
- Review
- 186 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K955033 (1996). 90 ancestors in all, the oldest K840643 (1984). 2 later devices descend from it, 1 citing it directly. 1 of the 92 devices in this family, counting this one, has a Class I recall.
- 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 deviceK112682 Metha Hip SystemAesculap Implant Systems, LLC · 2012
- Descendant · cites it directly · 1 of its ownK121684 Novation Lpi Prime Femoral StemExactech, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK141821 Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7…Exactech, Inc. · 2014 · Recalled
Class I recalls in this family
- K091423 Profemur Hip System Modular Necksdirect predicate · 2009
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) | K112682 | Metha Hip System | Aesculap Implant Systems, LLC | 2012 | — |
| +1 | K121684 | Novation Lpi Prime Femoral Stem | Exactech, Inc. | 2012 | — |
| +2 | K141821 | Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck… | Exactech, Inc. | 2014 | 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 | 3 | 0 |
| 1992 | 1 | 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 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K080584 | Metha Short Stem Hip SystemSummary page 1…LWJ, MEH, LZO SUBSTANTIAL EQUIVALENC Aesculap Implant Systems, LLC believes that the Metha Hip Systems are substantially equivalent to: * Metha Hip Systems (K080584 & K071916) * MAYO Conservative Hip Prosthesis (K030733 & K061 461) * Profemur Hip System Modular Necks (K091423)… | 2008 |
| * | K071916 | Metha Hip SystemSummary page 1…MEH, LZO SUBSTANTIAL EQUIVALENC Aesculap Implant Systems, LLC believes that the Metha Hip Systems are substantially equivalent to: * Metha Hip Systems (K080584 & K071916) * MAYO Conservative Hip Prosthesis (K030733 & K061 461) * Profemur Hip System Modular Necks (K091423)… | 2008 |
| * | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 SeriesSummary page 1…Systems, LLC believes that the Metha Hip Systems are substantially equivalent to: * Metha Hip Systems (K080584 & K071916) * MAYO Conservative Hip Prosthesis (K030733 & K061 461) * Profemur Hip System Modular Necks (K091423)… | 2003 |
| * | K061461 | Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Summary page 1…LLC believes that the Metha Hip Systems are substantially equivalent to: * Metha Hip Systems (K080584 & K071916) * MAYO Conservative Hip Prosthesis (K030733 & K061 461) * Profemur Hip System Modular Necks (K091423)… | 2006 |
| * | K091423 | Profemur Hip System Modular NecksSummary page 1…ially equivalent to: * Metha Hip Systems (K080584 & K071916) * MAYO Conservative Hip Prosthesis (K030733 & K061 461) * Profemur Hip System Modular Necks (K091423) 091… | 2009 |
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 |
|---|---|---|---|
| K121684 | Novation Lpi Prime Femoral Stem | 2012 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 25 of the 89 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K121684 (Exactech, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K080584.
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. 2012, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K112682 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112682: Metha Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112682
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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