510(k) · Cleared
Recalled · Class II · 2019Biolox Delta Ceramic Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 19, 2007 as substantially equivalent to K061312 (Biomet, Inc., 2006) and 1 other predicate after a 167-day review. Its family tree reaches back 6 generations to 1981. 217 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 19, 2007
- Review
- 167 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 6 generations to K810258 (1981). 24 ancestors in all. 217 later devices descend from it, 15 citing it directly.
- Root · 6 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 4 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 3 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 2 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 1 generation backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- This deviceK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007
- Descendant · cites it directly · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- Descendant · cites it directly · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 217 · See all- K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · cites it directly165descendants
- K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · cites it directly149descendants
- K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · cites it directly140descendants
- K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · 2 generations on110descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −5 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −4 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −3 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −2 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −1 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| 0 (this device) | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | — |
| +1 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| +1 | K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2009 | — |
| +1 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| +2 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 18 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 13 | 0 |
| 2019 | 17 | 0 |
| 2020 | 15 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 19 | 0 |
| 2026 | 12 | 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 LZO? 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061312 | 36MM Biolox Delta Ceramic Heads | 2006 |
| * | K062748 | Modification: to Depuy Delta Ceramic Femoral HeadSummary page 1…t2, cleared June 6, 2006 DePuy Delta Ceramic Fernoral Head, manmfacturcd by De P y, K062748, cleared November 30. 2006 V4(W'~' Hiolax delta Ceramic Femoral Heads,… | 2006 |
| Kept off the family tree | K052718 | FDA’s K052718 is V40 Biolox Delta Ceramic Femoral Heads Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
What descends from it? (217)
See all 21715 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve | 2008 | 165 |
| K083762 | Biolox Delta Ceramic Femoral Heads | 2009 | 149 |
| K100412 | Biolox Delta Ceramic Femoral Heads | 2010 | 140 |
| K082991 | Biolox Delta Ceramic Femoral Head | 2008 | 63 |
| K122158 | PBP Total Hip System | 2012 | 21 |
| K130899 | Biolox Delta Ceramic Femoral Heads | 2013 | 19 |
| K112115 | Mectacer Biolox (R) Delta Femoral Heads | 2011 | 14 |
| K163577 | Ecofit® Hip System | 2017 | 9 |
| K131684 | Biolox (R) Delta Ceramic Heads | 2013 | 9 |
| K150007 | Modified Bencox Hip System | 2015 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0336-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Dec 17, 2014 | Class II | Z-1134-2015 | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic… |
| Sep 4, 2012 | Class II | Z-0211-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K082844 (Encore Medical L.P., 2008) has gone furthest, with 165 descendants of its own.
- 6 other devices also cite its predicate K061312.
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. 2007, 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 BIOLOX defta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteparthritis, traumatic arthritis. polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabul, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with peeviously failed endoprostheses and/or total hip components in the operative extremity; and patients with agute 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/K071535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071535: Biolox Delta Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071535
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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