510(k) · Cleared
ClearedBIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 1, 2019 as substantially equivalent to K071535 (Zimmer, Inc., 2007) and 2 other predicates after a 27-day review. Its family tree reaches back 8 generations to 1981. 2 later devices descend from it.
- Decided
- Oct 1, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K810258 (1981). 91 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 4 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 3 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 2 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 1 generation backK130899 Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013
- This deviceK192416 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral…Zimmer GmbH · 2019
- Descendant · cites it directly · 0 of its ownK223828 BENCOX Delta Option HeadsCorentec Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −4 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −2 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −1 | K130899 | Biolox Delta Ceramic Femoral Heads | Zimmer GmbH | 2013 | — |
| 0 (this device) | K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH | 2019 | — |
| +1 | K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | 2023 | — |
| +1 | K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 11 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 5…nporous uncemented prosthesis Predicate Device: Biolox Delta Ceramic Femoral Heads, manufactured by Zimmer GmbH, K071535, cleared 11/19/2007 and K130899, cleared 05/01/2013… | 2007 |
| * | K130899 | Biolox Delta Ceramic Femoral HeadsSummary page 5…e: Biolox Delta Ceramic Femoral Heads, manufactured by Zimmer GmbH, K071535, cleared 11/19/2007 and K130899, cleared 05/01/2013 Biolox Option Ceramic Femoral Head Syst… | 2013 |
| * | K073567 | Biolox Option Ceramic Femoral Head System, Model 8777 SeriesSummary page 5…cleared 05/01/2013 Biolox Option Ceramic Femoral Head System, manufactured by Zimmer GmbH, K073567, cleared 03/13/2008 Device Description: The BIOLOX delta Ceramic Femoral Heads are fabricated from an… | 2008 |
What descends from it? (2)
2 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)
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 38 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 24 of the 91 ancestors have a recall of any class.
- Of its descendants, K223828 (Corentec Co., Ltd., 2023) has gone furthest, with 0 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. 2019, 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 delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, 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 acetabuli, or slipped capital…
Read the full statement (196 words)
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, 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 acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute femoral neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, 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 acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion.
• Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute neck fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192416: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192416
Report an extraction error
Are you the manufacturer?
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