510(k) · Cleared
Recalled · Class II · 2023Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 25, 2008 as substantially equivalent to K071535 (Zimmer, Inc., 2007) and 6 other predicates after a 60-day review. Its family tree reaches back 7 generations to 1981. 165 later devices descend from it. It has been recalled once.
- Decided
- Nov 25, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 7 generations to K810258 (1981). 27 ancestors in all. 165 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 4 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 3 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 2 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 1 generation backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- This deviceK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008
- 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
- Descendant · 3 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · 4 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
Showing 5 of 165 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 165 · See all- 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
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 3 generations on62descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −6 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −5 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −4 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −3 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −2 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −1 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| 0 (this device) | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | — |
| +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 | — |
| +3 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +4 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
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 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 15 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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? (7)
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 |
|---|---|---|---|
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 1…of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Predicate Devices: * Zimmer Biolox®t delta Ceramic Femoral Head - K07 1535, Cleared November 19, 2007 * Biomet Biolox delta Ceramic Head - K04209 1, Cleared March 25, 2005, K05141 1, Cleared June 29, 200… | 2007 |
| * | K042091 | Biolox Delta Ceramic HeadsSummary page 1…ng pain for many patients. Predicate Devices: * Zimmer Biolox®t delta Ceramic Femoral Head - K07 1535, Cleared November 19, 2007 * Biomet Biolox delta Ceramic Head - K04209 1, Cleared March 25, 2005, K05141 1, Cleared June 29, 2005, K0613 12, Cleared June 6, 2006 * DePuy Delta Ceramic Femoral Head -… | 2005 |
| * | K051411 | Arcomxl Polyethylene Liners and Biolox Delta HeadsSummary page 1…cate Devices: * Zimmer Biolox®t delta Ceramic Femoral Head - K07 1535, Cleared November 19, 2007 * Biomet Biolox delta Ceramic Head - K04209 1, Cleared March 25, 2005, K05141 1, Cleared June 29, 2005, K0613 12, Cleared June 6, 2006 * DePuy Delta Ceramic Femoral Head - K062748, Cleared November 30, 200… | 2005 |
| * | K061312 | 36MM Biolox Delta Ceramic HeadsSummary page 1…ta Ceramic Femoral Head - K07 1535, Cleared November 19, 2007 * Biomet Biolox delta Ceramic Head - K04209 1, Cleared March 25, 2005, K05141 1, Cleared June 29, 2005, K0613 12, Cleared June 6, 2006 * DePuy Delta Ceramic Femoral Head - K062748, Cleared November 30, 2006 * Stryker Howmedica Osteonics V4… | 2006 |
| * | K062748 | Modification: to Depuy Delta Ceramic Femoral HeadSummary page 1…et Biolox delta Ceramic Head - K04209 1, Cleared March 25, 2005, K05141 1, Cleared June 29, 2005, K0613 12, Cleared June 6, 2006 * DePuy Delta Ceramic Femoral Head - K062748, Cleared November 30, 2006 * Stryker Howmedica Osteonics V4OTm Biolox. delta Ceramic Femoral Head - K05278 1, Cleared October 2… | 2006 |
| * | K052718 | V40 Biolox Delta Ceramic Femoral Heads Our reading of the summary gave K052781, FDA’s number for Breformance (Bredent-Products For the Dental Technician Laborat). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stryker Howmedica Osteonics V40™ Biolox delta Ceramic Femoral Head”. | 2005 |
| * | K003379 | V-40/C-Taper Adapter SleeveSummary page 1…ker Howmedica Osteonics V4OTm Biolox. delta Ceramic Femoral Head - K05278 1, Cleared October 27, 2005 * Stryker Howmedica Osteonics V40Trm/C-Taper Adapter Sleeve - K003379, Cleared November 30, 2000 Comparable Featuresto Predicate Device(s): Features comparable to predicate devices include the same… | 2000 |
What descends from it? (165)
See all 1654 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2023 | Class II | Z-2604-2023 | Nonconforming Material/Component | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 27 ancestors have a recall of any class.
- Of its descendants, K100412 (Smith & Nephew, Inc., 2010) has gone furthest, with 140 descendants of its own.
- 14 other devices also cite its predicate K071535.
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. 2008, 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?
Joint replacement is indicated for patients suffering from disability due to:
* noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
* rheumatoid arthritis;
* correction of functional deformity;
* femoral fracture
This device may also be indicated in the salvage of previously failed surgical attempts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082844
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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