510(k) · Cleared
Cleared100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Cleared on Feb 11, 2009 as substantially equivalent to K070399 (Biomet Manufacturing, Inc., 2007) after a 27-day review. Its family tree reaches back 5 generations to 1981. 153 later devices descend from it.
- Decided
- Feb 11, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- MAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810258 (1981). 15 ancestors in all. 153 later devices descend from it, 2 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 backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 1 generation backK070399 100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc. · 2007
- This deviceK090103 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and…Biomet, Inc. · 2009
- Descendant · cites it directly · 114 of its ownK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- Descendant · 2 generations on · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- Descendant · cites it directly · 60 of its ownK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 153 · See all- K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · cites it directly114descendants
- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 2 generations on88descendants
- K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp · 2009 · cites it directly60descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
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 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −1 | K070399 | 100KGY E-Poly Acetabular Liners-Additional Profiles | Biomet Manufacturing, Inc. | 2007 | — |
| 0 (this device) | K090103 | 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall | Biomet, Inc. | 2009 | — |
| +1 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| +2 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| +1 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| +2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 9 | 0 |
| 2019 | 20 | 0 |
| 2020 | 13 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 17 | 0 |
| 2025 | 18 | 0 |
| 2026 | 19 | 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 MAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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…l/ceramic/polymer, cemented or non-porous, uncemented (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K070399, 100 kGy E- Poly T'M Acetabular Liners-Additional Profiles.… | 2007 |
What descends from it? (153)
See all 1532 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 2.1 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K100048 (Biomet Manufacturing Corp, 2010) has gone furthest, with 114 descendants of its own.
- 4 other devices also cite its predicate K070399.
How does its category compare?
All MAY devicesMAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MAY
Too few MAY 510(k)s in any year since 2007 to give a median.
Recalls per year · MAY
15in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAY
2in 2025
MAUDE reports naming product code MAY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 0 | — | 0 | 94 |
| 2015 | 0 | — | 0 | 115 |
| 2016 | 0 | — | 15 | 60 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 using other techniques.
5. Revision of previously, failed total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090103: 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090103
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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