510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Arcomxl Polyethylene Liners

K042051510(k) TraditionalCleared Mar 8, 2005221-day reviewClass II21 CFR 888.3358Recalls 1

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 Mar 8, 2005 as substantially equivalent to K023357 (Biomet Orthopedics, Inc., 2002) and 1 other predicate after a 221-day review. Its family tree reaches back 3 generations to 1981. 355 later devices descend from it. It has been recalled once.

Decided
Mar 8, 2005
Review
221 days
Class
Class II
Product code
LPH
Recalls
1
Predicates
2

Its longest line of descent runs back 3 generations to K810258 (1981). 13 ancestors in all. 355 later devices descend from it, 7 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 ancestors2019: 32 descendants cleared2012: 15 descendants cleared2016: 16 descendants cleared2011: 12 descendants cleared2005: 1 descendant cleared2006: 2 descendants cleared2009: 5 descendants cleared2007: 2 descendants cleared2008: 2 descendants cleared2015: 16 descendants cleared2018: 21 descendants cleared2025: 30 descendants cleared2014: 18 descendants cleared2013: 21 descendants cleared2024: 29 descendants cleared2010: 4 descendants cleared2020: 25 descendants cleared2022: 22 descendants cleared2017: 15 descendants cleared2021: 19 descendants cleared2026: 27 descendants cleared2023: 21 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: 7 descendants2 generations forward: 20 descendants3 generations forward: 32 descendants4 generations forward: 55 descendants5 generations forward: 70 descendants6 generations forward: 58 descendants7 generations forward: 50 descendants8 generations forward: 30 descendants9 generations forward: 23 descendants10 generations forward: 5 descendants11 generations forward: 2 descendants12 generations forward: 3 descendants 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 deviceK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005
  5. Descendant · cites it directly · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. Descendant · 2 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. Descendant · 3 generations on · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. Descendant · 2 generations on · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. Descendant · 2 generations on · 163 of its ownK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007

Showing 5 of 355 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 22008: 22009: 52010: 42011: 122012: 152013: 212014: 182015: 162016: 162017: 152018: 212019: 322020: 252021: 192022: 222023: 212024: 292025: 302026: 27
2005high 32 (2019) · low 1 (2005)2026

Most influential descendants

Showing 5 of 355 · See all
  • K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · cites it directly344descendants
  • K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 2 generations on343descendants
  • K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · 3 generations on217descendants
  • K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · 2 generations on165descendants
  • K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007 · 2 generations on163descendants
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)K042051Arcomxl Polyethylene LinersBiomet, Inc.2005—
+1K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
+2K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
+3K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
+2K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
+2K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—

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
200510
200620
200720
200820
200950
201040
2011120
2012150
2013210
2014180
2015160
2016160
2017150
2018210
2019320
2020250
2021190
2022220
2023210
2024290
2025300
2026270
FIG. 1 — Lineage of K042051, 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
…- hip joint metal/polymer semi-constrained cemented prosthesis (888.3350) Substantially Equivalent Devices: -ArComre Polyethylene Uners and Components (K023357) -RingLoc® 36mm Liners (K032396) Device Description: Biomet Manufacturing Corp. is m…
Biomet Orthopedics, Inc.20021
*K032396Ringloc 36MM Line and Modular Femoral Heads
Summary page 1
…888.3350) Substantially Equivalent Devices: -ArComre Polyethylene Uners and Components (K023357) -RingLoc® 36mm Liners (K032396) Device Description: Biomet Manufacturing Corp. is modifying the manufacturing process of UHMWPE used i…
Biomet, Inc.20033

Also cleared against K023357: 4 other devices →

What descends from it? (355)

See all 355

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

NumberDeviceApplicantDecidedDescendants
K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.2005344
K110555Arcomxl Active ArticulationBiomet Manufacturing Corp201122
K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212
K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211
K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162
K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190
K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 17, 2017Class IIZ-1860-2017Process designEndotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

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, K051411 (Biomet, Inc., 2005) has gone furthest, with 344 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) NonInflammatory 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 arthropiasty.

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
  • K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
  • K042989RX90 Low Profile Acetabular SystemBiomet, Inc. · 2005

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/K042051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042051: Arcomxl Polyethylene Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042051

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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