510(k) · Cleared
Recalled · Class II · 2017Biolox (R) 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 Oct 10, 2013 as substantially equivalent to K042091 (Biomet, Inc., 2005) and 2 other predicates after a 122-day review. Its family tree reaches back 7 generations to 1981. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 10, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K810258 (1981). 25 ancestors in all. 9 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 deviceK131684 Biolox (R) Delta Ceramic HeadsBiomet, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK141653 Biolox Delta Ceramic Option HeadsBiomet, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK192683 Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK181171 Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K141653Biolox Delta Ceramic Option HeadsBiomet, Inc. · 2014 · cites it directly4descendants
- K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd. · 2020 · cites it directly2descendants
- K181171Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019 · cites it directly2descendants
- K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · 2 generations on1descendant
- K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025 · 2 generations on0descendants
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) | K131684 | Biolox (R) Delta Ceramic Heads | Biomet, Inc. | 2013 | — |
| +1 | K141653 | Biolox Delta Ceramic Option Heads | Biomet, Inc. | 2014 | — |
| +1 | K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | Biomet UK, Ltd. | 2020 | — |
| +1 | K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | 2019 | 5 |
| +2 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +2 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2025 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042091 | Biolox Delta Ceramic HeadsSummary page 2…or non-porous cemented, osteophilic finish (21 CFR 888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Hecads-Biomet-(K04209 1) 36mm BioloxO delta Ceramic fieads-Biomet-(K061312) Hioloxv delta Ceramic Head-Zimmer-(K071535) Device Description: The Biolox… | 2005 |
| * | K061312 | 36MM Biolox Delta Ceramic HeadsSummary page 2…88.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Hecads-Biomet-(K04209 1) 36mm BioloxO delta Ceramic fieads-Biomet-(K061312) Hioloxv delta Ceramic Head-Zimmer-(K071535) Device Description: The Biolox® delta component isa traditional, one-piece cerami… | 2006 |
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 2…Substantial Equivalence Is Claimed: Biolox® delta Ceramic Hecads-Biomet-(K04209 1) 36mm BioloxO delta Ceramic fieads-Biomet-(K061312) Hioloxv delta Ceramic Head-Zimmer-(K071535) Device Description: The Biolox® delta component isa traditional, one-piece ceramic head indicated for hip arthroplasty. The m… | 2007 |
What descends from it? (9)
4 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 |
|---|---|---|---|---|
| Jun 30, 2017 | Class II | Z-0992-2018 | Packaging process control | Product may contain the presence of melted sterile packaging upon opening. |
| Jun 30, 2017 | Class II | Z-0993-2018 | Packaging process control | For soft tissue fixation |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 25 ancestors have a recall of any class.
- Of its descendants, K141653 (Biomet, Inc., 2014) has gone furthest, with 4 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. 2013, 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, avascular necrosis and traumatic arthritis. 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…
Read the full statement (163 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, avascular necrosis and traumatic arthritis.
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, K021 380, K033871 )*
Interlocking hip stems are indicated for nan-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)*
*Note - for the USA only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131684: Biolox (R) Delta 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/K131684
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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