510(k) · Cleared
Recalled · 2006Mayo Conservative Hip Prosthesis, Model 8026 Series
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 May 1, 2003 as substantially equivalent to K943230 (Mayo Clinic, 1997) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1985. 296 later devices descend from it. It has been recalled 2 times.
- Decided
- May 1, 2003
- Review
- 52 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K850055 (1985). 14 ancestors in all, the oldest K840643 (1984). 296 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 2 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 1 generation backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- This deviceK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003
- Descendant · cites it directly · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · 3 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 4 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
Showing 5 of 296 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 296 · See all- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · cites it directly267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 2 generations on166descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 3 generations on117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −2 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −1 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| 0 (this device) | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | — |
| +1 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +3 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 15 | 0 |
| 2012 | 25 | 0 |
| 2013 | 22 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 10 | 0 |
| 2017 | 17 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 17 | 0 |
| 2023 | 18 | 0 |
| 2024 | 16 | 0 |
| 2025 | 22 | 0 |
| 2026 | 20 | 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 24.3 · 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? (3)
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 |
|---|---|---|---|
| * | K943230 | Mayo Hip ProsthesisSummary page 1…21 CFR 9 888.3358 Predicate Devices: MA YO Conservative Hip Prosthesis, manufactured by Zimmer, K943230, cleared January 14, 1997 VerS’sB Fiber Metal Taper Hip Prosthesis,… | 1997 |
| * | K964769 | Versys Hip System--Fiber Metal Taper Hip ProsthesisSummary page 1…cleared January 14, 1997 VerS’sB Fiber Metal Taper Hip Prosthesis, manufactured by Zimmer, K964769, cleared February 13, 1997 Harris/Galante Hip Syste… | 1997 |
| * | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingSummary page 1…Harris/Galante Hip System with CalcicoatB Ceramic Coating, manufactured by Zimmer, K9807 1 1. cleared November 12. 1998 Device Description: Like the predicate MA YO Hip, the MA YO 12/14 Hip… | 1998 |
What descends from it? (296)
See all 2968 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040191 | Bicontact Hip Stem and Femoral Head | 2004 | 267 |
| K080584 | Metha Short Stem Hip System | 2008 | 83 |
| K071916 | Metha Hip System | 2008 | 68 |
| K072417 | Smith & Nephew Mis Hip Stem | 2008 | 44 |
| K083312 | Minihip Stem | 2010 | 15 |
| K061461 | Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05 | 2006 | 5 |
| K102172 | Msa Hip System | 2011 | 3 |
| K112682 | Metha Hip System | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2006 | Not classified | Z-1474-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1475-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K040191 (Aesculap, 2004) has gone furthest, with 267 descendants of its own.
- 3 other devices also cite its predicate K943230.
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 M A YO 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 femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030733
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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