510(k) · Cleared
Recalled · Class II · 2024Biolox Delta Option Ceramic Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jan 15, 2009 as substantially equivalent to K042091 (Biomet, Inc., 2005) and 3 other predicates after a 99-day review. Its family tree reaches back 7 generations to 1981. 61 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 15, 2009
- Review
- 99 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 7 generations to K810258 (1981). 26 ancestors in all. 61 later devices descend from it, 3 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 backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- This deviceK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009
- Descendant · cites it directly · 60 of its ownK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 3 generations on · 17 of its ownK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp · 2009 · cites it directly60descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 3 generations on35descendants
- K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015 · 3 generations on17descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 4 generations on8descendants
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 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| 0 (this device) | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | — |
| +1 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| +2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +3 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +3 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| +4 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
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 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 9 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 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? (4)
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 |
|---|---|---|---|
| * | K042091 | Biolox Delta Ceramic HeadsSummary page 1…trained cemented or nonporous uncemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® de/ta Ceramic Heads - K04209 1,K05141 1,K061312, K073102 Device Description: Biolox® delta Option Ceramic Heads are designed to be the bearing surface… | 2005 |
| * | K051411 | Arcomxl Polyethylene Liners and Biolox Delta HeadsSummary page 1…cemented or nonporous uncemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® de/ta Ceramic Heads - K04209 1,K05141 1,K061312, K073102 Device Description: Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a tot… | 2005 |
| * | K061312 | 36MM Biolox Delta Ceramic HeadsSummary page 1…nted or nonporous uncemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® de/ta Ceramic Heads - K04209 1,K05141 1,K061312, K073102 Device Description: Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip j… | 2006 |
| * | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersSummary page 1…onporous uncemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® de/ta Ceramic Heads - K04209 1,K05141 1,K061312, K073102 Device Description: Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint repl… | 2007 |
| † | K974558 | Salvage/Onocology Hip and Total Femur System | 1998 |
| † | K002757 | Oncology Salvage System | 2000 |
| † | K021380 | Oss Les Proximal Femoral Component | 2002 |
| † | K033871 | IM Total Femur | 2004 |
| † | K990830 | Mallory/Head Calcar Replacement with Interlocking Slots BI-Metric Porous Collared Stem… | 2000 |
| † | K042774 | Mallory-Head Modular Calcar Stems with Interlocking Slots | 2005 |
What descends from it? (61)
See all 613 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 8, 2024 | Class II | Z-3132-2024 | Under Investigation by firm | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device… |
| Aug 8, 2024 | Class II | Z-3133-2024 | Under Investigation by firm | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device… |
| Jun 5, 2017 | Class II | Z-0302-2018 | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. |
| Jun 5, 2017 | Class II | Z-0301-2018 | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K093549 (Biomet Manufacturing Corp, 2009) has gone furthest, with 60 descendants of its own.
- 6 other devices also cite its predicate K042091.
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. 2009, 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?
Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other…
Read the full statement (148 words)
Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2) Rheumatoid arthritis
3) Correction of functional deformity
4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5) Revision procedures where other treatment or devices have failed.
Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082996: Biolox Delta Option Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082996
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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