510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Arcomxl Polyethylene Liners and Biolox Delta Heads

K051411510(k) SpecialCleared Jun 29, 200529-day reviewClass II21 CFR 888.3353Recalls 1

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

Biomet, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jun 29, 2005 as substantially equivalent to K042051 (Biomet, Inc., 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1981. 344 later devices descend from it. It has been recalled once.

Decided
Jun 29, 2005
Review
29 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to K810258 (1981). 20 ancestors in all. 344 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors1994: 4 other ancestors1991: 1 other ancestor1997: 1 other ancestor1995: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors2012: 13 descendants cleared2006: 1 descendant cleared2009: 5 descendants cleared2011: 12 descendants cleared2007: 2 descendants cleared2008: 2 descendants cleared2013: 20 descendants cleared2010: 4 descendants cleared2020: 25 descendants cleared2025: 30 descendants cleared2014: 15 descendants cleared2022: 22 descendants cleared2017: 15 descendants cleared2015: 16 descendants cleared2016: 15 descendants cleared2019: 31 descendants cleared2018: 20 descendants cleared2021: 19 descendants cleared2023: 21 descendants cleared2026: 27 descendants cleared2024: 29 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 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 8 other ancestors4 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 16 descendants3 generations forward: 48 descendants4 generations forward: 80 descendants5 generations forward: 78 descendants6 generations forward: 53 descendants7 generations forward: 30 descendants8 generations forward: 23 descendants9 generations forward: 5 descendants10 generations forward: 2 descendants11 generations forward: 3 descendants K042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · 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 · 4 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 3 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 2 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 1 generation backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. This deviceK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005
  6. Descendant · cites it directly · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. Descendant · 2 generations on · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. Descendant · cites it directly · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. Descendant · cites it directly · 163 of its ownK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  10. Descendant · 3 generations on · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009

Showing 5 of 344 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 52010: 42011: 122012: 132013: 202014: 152015: 162016: 152017: 152018: 202019: 312020: 252021: 192022: 222023: 212024: 292025: 302026: 27
2006high 31 (2019) · low 1 (2006)2026

Most influential descendants

Showing 5 of 344 · See all
  • K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · cites it directly343descendants
  • K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · 2 generations on217descendants
  • K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · cites it directly165descendants
  • K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007 · cites it directly163descendants
  • K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · 3 generations on149descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−3K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−2K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−1K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
0 (this device)K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.2005—
+1K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
+2K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
+1K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
+1K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
+3K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199220
199310
199440
199530
199710
200220
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200950
201040
2011120
2012130
2013200
2014150
2015160
2016150
2017150
2018200
2019310
2020250
2021190
2022220
2023210
2024290
2025300
2026270
FIG. 1 — Lineage of K051411, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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
*K042051Arcomxl Polyethylene Liners
Summary page 1
…r, semi-constrained, cemented or non- cemented prosthesis (888.3353) Substantially Equivalent Devices: ArComXL'TM Acetabular Liners (K042051) BioloO delta Ceramic Heads (K042091) Device Description: The ArComX…
Biomet, Inc.20051
*K042091Biolox Delta Ceramic Heads
Summary page 1
…53) Substantially Equivalent Devices: ArComXL'TM Acetabular Liners (K042051) BioloO delta Ceramic Heads (K042091) Device Description: The ArComXL TM polyethylene liners are manufactured from highly cross-…
Biomet, Inc.20052

Also cleared against K042051: 6 other devices →

What descends from it? (344)

See all 344

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

NumberDeviceApplicantDecidedDescendants
K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343
K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.2008165
K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163
K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.200961
K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128
K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation20118

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 17, 2020Class IIZ-2145-2020Process controlPotential presence of elevated endotoxin levels that exceed the specification limit

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.
  • 5 of the 20 ancestors have a recall of any class.
  • Of its descendants, K061312 (Biomet, Inc., 2006) has gone furthest, with 343 descendants of its own.
  • 6 other devices also cite its predicate K042051.

How does its category compare?

All LZO devices

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

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

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 arthmoplasty.

Intended for cemented and uncemented applications

Indications for use as stated in the FDA summary.

Also cleared against K042051

6 other devices cite the same predicate.

  • K181491Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
  • K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  • K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  • K121034Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
  • K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 20112 recalls
  • K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp · 20062 recalls

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 LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K051411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051411

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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