510(k) · Cleared
ClearedBiolox® Delta Revision heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Limacorporate · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 4, 2025 as substantially equivalent to K213580 (Total Joint Othopedics, Inc., 2021) and 2 other predicates after an 83-day review. Its family tree reaches back 13 generations to 1981. 1 of the 198 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 4, 2025
- Review
- 83 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K810258 (1981). 197 ancestors in all. No later device cites it as a predicate yet. 1 of the 198 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- 2 generations backK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- 1 generation backK213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
- This deviceK243809 Biolox® Delta Revision headsLimacorporate · 2025
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 5 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 4 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 3 generations backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- 2 generations backK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- 1 generation backK213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc. · 2021
- This deviceK243809 Biolox® Delta Revision headsLimacorporate · 2025
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks2 generations back · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −6 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −5 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| −4 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| −3 | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
| −2 | K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018 | — |
| −1 | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | 2021 | — |
| 0 (this device) | K243809 | Biolox® Delta Revision heads | Limacorporate | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 21 | 0 |
| 1995 | 16 | 0 |
| 1996 | 13 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 17 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 13 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 1 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthSummary page 8…K243809 1 (Primary predicate) TJO Biolox Option Ceramic Heads Line K213580 Extension 2 (Additional predicate) Biomet UK Biolox® Delta Option Ceramic Head… | 2021 |
| * | K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsSummary page 8…ption Ceramic Heads Line K213580 Extension 2 (Additional predicate) Biomet UK Biolox® Delta Option Ceramic Heads K192683 3 (Additional predicate) Limacorporate CoCrMo Femoral heads K112158 Summary of technology comparison: TJO B… | 2020 |
| * | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsSummary page 8…n 2 (Additional predicate) Biomet UK Biolox® Delta Option Ceramic Heads K192683 3 (Additional predicate) Limacorporate CoCrMo Femoral heads K112158 Summary of technology comparison: TJO Biolox® Option Ceramic Heads Line Extension and Biomet UK Biolox® Delta Option Ceramic He… | 2012 |
| † | K141327 | Minima S System | 2014 |
| † | K182099 | Delta TT Pro | 2018 |
| † | K170473 | C2 femoral stem | 2017 |
| † | K112091 | H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads | 2012 |
| † | K160011 | H-Max S stem | 2016 |
| † | K140975 | Mastersl Femoral Stem | 2014 |
| † | K151739 | Revision Femoral Stem | 2015 |
| † | K161226 | Revision Femoral Stem | 2017 |
| † | K143509 | MasterSL femoral stem | 2015 |
| † | K150855 | H-MAX S Femoral Hip System | 2015 |
| † | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 |
| † | K141395 | Delta TT Acetabular System | 2014 |
| † | K181491 | Delta Dual Mobility System | 2019 |
| † | K191622 | Delta Multihole TT Pro Acetabular System | 2019 |
| † | K200656 | Delta Multihole TT Pro Acetabular System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 44 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 44 of the 197 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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?
LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components. - Coupling of femoral modular heads with DELTA Acetabular System is indicated for use for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; •…
Read the full statement (360 words)
LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.
- Coupling of femoral modular heads with DELTA Acetabular System is indicated for use for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• Post-traumatic arthritis,
• Correction of functional deformity;
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
• Revisions in cases of good remaining bone stock.
• Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only)
The components are intended for use in cementless (press-fit) applications.
- Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• rheumatoid arthritis;
• osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem);
• treatment of femoral head and neck fractures (Minima S and MasterSL stems)
• correction of functional deformity (MODULUS stems);
• revisions in cases of good remaining femoral bone stock.
The components are intended for use in cementless (press-fit) applications.
- Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications.
- Coupling of femoral modular heads with Cemented Cup is intended for cemented applications in hip arthroplasty where the acetabular socket needs reconstruction.
LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications.
This procedure is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243809: Biolox® Delta Revision heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243809
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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