510(k) Report

510(k) · Cleared

Cleared

E-Poly (Vitamin E) Acetabular Liners

K050327510(k) TraditionalCleared Sep 27, 2005230-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Sep 27, 2005 as substantially equivalent to K023357 (Biomet Orthopedics, Inc., 2002) and 1 other predicate after a 230-day review. Its family tree reaches back 3 generations to 1981. 289 later devices descend from it.

Decided
Sep 27, 2005
Review
230 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K810258 (1981). 13 ancestors in all. 289 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors1993: 1 other ancestor1992: 2 other ancestors2007: 3 descendants cleared2011: 2 descendants cleared2012: 10 descendants cleared2010: 3 descendants cleared2008: 1 descendant cleared2009: 3 descendants cleared2015: 12 descendants cleared2016: 14 descendants cleared2013: 13 descendants cleared2019: 23 descendants cleared2014: 18 descendants cleared2017: 8 descendants cleared2025: 27 descendants cleared2021: 23 descendants cleared2018: 15 descendants cleared2026: 26 descendants cleared2024: 22 descendants cleared2023: 21 descendants cleared2020: 22 descendants cleared2022: 23 descendants clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 7 other ancestors3 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 27 descendants4 generations forward: 68 descendants5 generations forward: 77 descendants6 generations forward: 49 descendants7 generations forward: 30 descendants8 generations forward: 17 descendants9 generations forward: 6 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 19810+5+10
  1. Root · 3 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 2 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 1 generation backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. This deviceK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  5. Descendant · cites it directly · 286 of its ownK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
  6. Descendant · 2 generations on · 248 of its ownK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  7. Descendant · cites it directly · 165 of its ownK070399 100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc. · 2007
  8. Descendant · 2 generations on · 163 of its ownK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  9. Descendant · 2 generations on · 153 of its ownK090103 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and…Biomet, Inc. · 2009

Showing 5 of 289 descendants. See all descendants

Descendants cleared per year

2007: 32008: 12009: 32010: 32011: 22012: 102013: 132014: 182015: 122016: 142017: 82018: 152019: 232020: 222021: 232022: 232023: 212024: 222025: 272026: 26
2007high 27 (2025) · low 1 (2008)2026

Most influential descendants

Showing 5 of 289 · See all
  • K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007 · cites it directly286descendants
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008 · 2 generations on248descendants
  • K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc. · 2007 · cites it directly165descendants
  • K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007 · 2 generations on163descendants
  • K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc. · 2009 · 2 generations on153descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−2K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−1K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
0 (this device)K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—
+1K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007—
+2K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008—
+1K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007—
+2K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
+2K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199420
199530
199710
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200810
200930
201030
201120
2012100
2013130
2014180
2015120
2016140
201780
2018150
2019230
2020220
2021230
2022230
2023210
2024220
2025270
2026260
FIG. 1 — Lineage of K050327, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K023357Arcpm 1050 Resin-Hips
Summary page 1
…rained, uncernented, metal/polymer, (888.3358) Substantially Equivalent Devices: -ArCorn® Polyethylene Liners and Components (K(023357) -RingLoc® 36mm Liners (K(032396)…
Biomet Orthopedics, Inc.20021
*K032396Ringloc 36MM Line and Modular Femoral Heads
Summary page 1
…358) Substantially Equivalent Devices: -ArCorn® Polyethylene Liners and Components (K(023357) -RingLoc® 36mm Liners (K(032396) modifying the manufacturing process of ultra-high Device Description: Bio…
Biomet, Inc.20033

Also cleared against K023357: 4 other devices →

What descends from it? (289)

See all 289

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286
K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165
K101336E1 Avantage HeadBiomet Manufacturing Corp201124

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 24 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K070364 (Biomet, Inc., 2007) has gone furthest, with 286 descendants of its own.
  • 4 other devices also cite its predicate K023357.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

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

Indications for use as stated in the FDA summary.

Also cleared against K023357

4 other devices cite the same predicate.

  • K181491Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
  • K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp · 20062 recalls
  • K042989RX90 Low Profile Acetabular SystemBiomet, Inc. · 2005
  • K042051Arcomxl Polyethylene LinersBiomet, Inc. · 20051 recall

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K050327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050327: E-Poly (Vitamin E) 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/K050327

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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