510(k) · Cleared
ClearedE-Poly Tibial Bearings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 17, 2008 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 3 other predicates after a 112-day review. Its family tree reaches back 5 generations to 1981. 248 later devices descend from it.
- Decided
- Jun 17, 2008
- Review
- 112 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K810258 (1981). 20 ancestors in all. 248 later devices descend from it, 6 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 backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- This deviceK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 248 · See all- K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · cites it directly119descendants
- K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · cites it directly114descendants
- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 2 generations on88descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
- K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · cites it directly46descendants
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 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| 0 (this device) | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| +1 | 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 | — |
| +2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +1 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 15 | 0 |
| 2015 | 10 | 0 |
| 2016 | 14 | 0 |
| 2017 | 8 | 0 |
| 2018 | 12 | 0 |
| 2019 | 17 | 0 |
| 2020 | 19 | 0 |
| 2021 | 23 | 0 |
| 2022 | 20 | 0 |
| 2023 | 19 | 0 |
| 2024 | 21 | 0 |
| 2025 | 24 | 0 |
| 2026 | 20 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K023546 | Maxim Accel Knee SystemSummary page 1…prosthesis (888.3560), JWH Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim Accel Knee System K023546 Biomet Inc. Maxim Accel (Vanguard TM ) PS & Bearings K041046 Biomet Inc. Vanguard T… | 2003 |
| * | K041046 | Maxim Accel (Vanguard) PS+ BearingsSummary page 1…ntial Equivalence Is Claimed: Maxim Accel Knee System K023546 Biomet Inc. Maxim Accel (Vanguard TM ) PS & Bearings K041046 Biomet Inc. Vanguard TM Anterior Stabilized Tibial Bearings K050222 Biomet Inc. lOOkGy E-P… | 2004 |
| * | K050222 | Vanguard Anterior Stabilized Tibial BearingsSummary page 1…Biomet Inc. Maxim Accel (Vanguard TM ) PS & Bearings K041046 Biomet Inc. Vanguard TM Anterior Stabilized Tibial Bearings K050222 Biomet Inc. lOOkGy E-PolyTM MaxRomn Acetabular Liners K070364 Biomet Inc. Device Des… | 2005 |
| * | K070364 | 100KGY E-Poly Maxrom Acetabular LinersSummary page 1…Biomet Inc. Vanguard TM Anterior Stabilized Tibial Bearings K050222 Biomet Inc. lOOkGy E-PolyTM MaxRomn Acetabular Liners K070364 Biomet Inc. Device Description: The E-PolyTm Tibial Bearings are provided infive sizes. Each size comes infive… | 2007 |
What descends from it? (248)
See all 2486 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | 2010 | 119 |
| K100048 | E1 Antioxidant Infused Technology | 2010 | 114 |
| K113550 | Vanguard Complete Knee System | 2012 | 46 |
| K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | 2013 | 33 |
| K122160 | Vanguard XP Knee System | 2013 | 6 |
| K183583 | Vanguard Complete Knee System | 2019 | 1 |
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 27 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K091956 (Encore Medical L.P., 2010) has gone furthest, with 119 descendants of its own.
- 14 other devices also cite its predicate K023546.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
For cemented and un-cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080528: E-Poly Tibial Bearings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080528
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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