510(k) · Cleared
Cleared36MM Biolox Delta 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 Jun 6, 2006 as substantially equivalent to K042091 (Biomet, Inc., 2005) and 1 other predicate after a 27-day review. Its family tree reaches back 5 generations to 1981. 343 later devices descend from it.
- Decided
- Jun 6, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K810258 (1981). 21 ancestors in all. 343 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 4 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 3 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 2 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 1 generation backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- This deviceK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- Descendant · cites it directly · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 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 · 163 of its ownK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- Descendant · 2 generations on · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
Showing 5 of 343 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 343 · See all- K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · cites it directly217descendants
- K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · cites it directly165descendants
- K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007 · cites it directly163descendants
- K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · 2 generations on149descendants
- K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 2 generations on140descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −4 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −3 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −2 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −1 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| 0 (this device) | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| +1 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| +1 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| +1 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| +2 | K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 12 | 0 |
| 2012 | 13 | 0 |
| 2013 | 20 | 0 |
| 2014 | 15 | 0 |
| 2015 | 16 | 0 |
| 2016 | 15 | 0 |
| 2017 | 15 | 0 |
| 2018 | 20 | 0 |
| 2019 | 31 | 0 |
| 2020 | 25 | 0 |
| 2021 | 19 | 0 |
| 2022 | 22 | 0 |
| 2023 | 21 | 0 |
| 2024 | 29 | 0 |
| 2025 | 30 | 0 |
| 2026 | 27 | 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? (2)
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…/ceramic/polymer semiconstrained cemented or non-cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091 & K051411 Device Description: Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacemen… | 2005 |
| * | K051411 | Arcomxl Polyethylene Liners and Biolox Delta HeadsSummary page 1…olymer semiconstrained cemented or non-cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091 & K051411 Device Description: Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The hig… | 2005 |
| † | 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? (343)
See all 3437 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071535 | Biolox Delta Ceramic Femoral Head | 2007 | 217 |
| K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve | 2008 | 165 |
| K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | 2007 | 163 |
| K082996 | Biolox Delta Option Ceramic Heads | 2009 | 61 |
| K131684 | Biolox (R) Delta Ceramic Heads | 2013 | 9 |
| K112897 | Renovis Surgical Hip Joint Replacement Prosthesis | 2012 | 8 |
| K112463 | United 36MM Ceramic Femoral Head, Delta | 2011 | 8 |
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 25 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K071535 (Zimmer, Inc., 2007) has gone furthest, with 217 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.
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?
BioloxV 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 osteoarthuitis 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 (154 words)
BioloxV 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 osteoarthuitis 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. (K974558, K002757, K021380, K033871)
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. (K990830, K042774)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061312: 36MM Biolox Delta Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061312
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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