510(k) · Cleared
Cleared44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 16, 2009 as substantially equivalent to K070399 (Biomet Manufacturing, Inc., 2007) and 2 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1981. 60 later devices descend from it.
- Decided
- Dec 16, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K810258 (1981). 28 ancestors in all. 60 later devices descend from it, 3 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 backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 1 generation backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- This deviceK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- Descendant · cites it directly · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 2 generations on · 17 of its ownK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · cites it directly53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 2 generations on35descendants
- K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015 · 2 generations on17descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 3 generations on8descendants
- K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019 · 2 generations on8descendants
View 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 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −1 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| 0 (this device) | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| +1 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +2 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +2 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| +3 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +2 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K070399 | 100KGY E-Poly Acetabular Liners-Additional ProfilesSummary page 1…non-porous, uncemented (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 100 kGy E-Poly'" Acetabular Liners - K070399 and K090103, Biolox® delta Option Ceramic Heads - K082996. Device Description: Biomet Manufacturing… | 2007 |
| * | K090103 | 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallSummary page 1…uncemented (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 100 kGy E-Poly'" Acetabular Liners - K070399 and K090103, Biolox® delta Option Ceramic Heads - K082996. Device Description: Biomet Manufacturing Corp. is add… | 2009 |
| * | K082996 | Biolox Delta Option Ceramic HeadsSummary page 1…s To Which Substantial Equivalence Is Claimed: 100 kGy E-Poly'" Acetabular Liners - K070399 and K090103, Biolox® delta Option Ceramic Heads - K082996. Device Description: Biomet Manufacturing Corp. is adding a size 44mm liner to their line of El'" Ac… | 2009 |
What descends from it? (60)
See all 603 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 28 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K121874 (Biomet Manufacturing Corp, 2012) has gone furthest, with 53 descendants of its own.
- 4 other devices also cite its predicate K070399.
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?
The 44mm El Tm Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M 2a Magnum T M Modular Head is 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…
Read the full statement (176 words)
The 44mm El Tm Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M 2a Magnum T M Modular Head is 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 44mm Biolox® delta Option Ceramic Head 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. (K9 74558, K002757, K021380, K033871)
Inte flocking 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 pmosthesis. (K990830, K042 774)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093549
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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