510(k) · Cleared
ClearedMayo Conservative Hip Prosthesis, Model 00.65-8026-010-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 20, 2006 as substantially equivalent to K030733 (Zimmer, Inc., 2003) after a 208-day review. Its family tree reaches back 4 generations to 1985. 5 later devices descend from it.
- Decided
- Dec 20, 2006
- Review
- 208 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850055 (1985). 15 ancestors in all, the oldest K840643 (1984). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 3 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 2 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 1 generation backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- This deviceK061461 Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Zimmer, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK112682 Metha Hip SystemAesculap Implant Systems, LLC · 2012
- Descendant · cites it directly · 1 of its ownK140547 Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK121684 Novation Lpi Prime Femoral StemExactech, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK153057 FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK141821 Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7…Exactech, Inc. · 2014 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K112682Metha Hip SystemAesculap Implant Systems, LLC · 2012 · cites it directly2descendants
- K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2015 · cites it directly1descendant
- K121684Novation Lpi Prime Femoral StemExactech, Inc. · 2012 · 2 generations on1descendant
- K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. · 2016 · 2 generations on0descendants
- K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −3 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −2 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −1 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| 0 (this device) | K061461 | Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05 | Zimmer, Inc. | 2006 | — |
| +1 | K112682 | Metha Hip System | Aesculap Implant Systems, LLC | 2012 | — |
| +1 | K140547 | Excera Fitrite Total Hip Arthroplasty System | Excera Orthopedics, Inc. | 2015 | — |
| +2 | K121684 | Novation Lpi Prime Femoral Stem | Exactech, Inc. | 2012 | — |
| +2 | K153057 | FitRite™ Total Hip Arthroplasty System | Excera Orthopedics, Inc. | 2016 | — |
| +3 | 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 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 SeriesSummary page 1…§ 888.3358 Predicate Device: MAYO Conservative Hip Prosthesis, manufactured by Zimmer, Inc., K030733, cleared May 1,2003 Device Description: Like its predicate, the modified MAYO Conservative… | 2003 |
What descends from it? (5)
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 21 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K112682 (Aesculap Implant Systems, LLC, 2012) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K030733.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital fernoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061461: Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061461
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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