510(k) · Cleared
Cleared100KGY E-Poly Maxrom Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on May 3, 2007 as substantially equivalent to K050327 (Biomet, Inc., 2005) after an 85-day review. Its family tree reaches back 4 generations to 1981. 286 later devices descend from it.
- Decided
- May 3, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K810258 (1981). 14 ancestors in all. 286 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 3 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 2 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 1 generation backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- This deviceK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- Descendant · cites it directly · 248 of its ownK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- Descendant · cites it directly · 163 of its ownK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- Descendant · 2 generations on · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 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
Showing 5 of 286 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 286 · See all- K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008 · cites it directly248descendants
- K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007 · cites it directly163descendants
- K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · 2 generations on119descendants
- K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · cites it directly114descendants
- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 2 generations on88descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −3 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −2 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −1 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| 0 (this device) | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| +1 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| +1 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| +2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| +1 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| +2 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 18 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 8 | 0 |
| 2018 | 15 | 0 |
| 2019 | 23 | 0 |
| 2020 | 22 | 0 |
| 2021 | 23 | 0 |
| 2022 | 23 | 0 |
| 2023 | 21 | 0 |
| 2024 | 22 | 0 |
| 2025 | 27 | 0 |
| 2026 | 26 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K050327 | E-Poly (Vitamin E) Acetabular LinersSummary page 1…hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K050327- E- Poly" (Vitamin E)Acetabular Liners Device Description: Biomet Manufacturing Corp. is modifying the manufacturing process of u… | 2005 |
What descends from it? (286)
See all 2865 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 26 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K080528 (Biomet Orthopedics, Inc., 2008) has gone furthest, with 248 descendants of its own.
- 2 other devices also cite its predicate K050327.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
1) Non-inflammatory degenerative joint disease including osteaarthritis 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070364: 100KGY E-Poly Maxrom Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070364
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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