510(k) Report

510(k) · Cleared

Cleared

Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners

K073102510(k) SpecialCleared Nov 27, 200725-day reviewClass II21 CFR 888.3353

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

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

Cleared on Nov 27, 2007 as substantially equivalent to K042091 (Biomet, Inc., 2005) and 4 other predicates after a 25-day review. Its family tree reaches back 6 generations to 1981. 163 later devices descend from it.

Decided
Nov 27, 2007
Review
25 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K810258 (1981). 25 ancestors in all. 163 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2005: 2 other ancestors2003: 1 other ancestor1994: 4 other ancestors1991: 1 other ancestor2002: 2 other ancestors1997: 1 other ancestor1995: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors2012: 6 descendants cleared2010: 1 descendant cleared2009: 2 descendants cleared2013: 3 descendants cleared2014: 7 descendants cleared2011: 2 descendants cleared2017: 2 descendants cleared2015: 6 descendants cleared2016: 4 descendants cleared2025: 19 descendants cleared2019: 20 descendants cleared2020: 15 descendants cleared2018: 9 descendants cleared2022: 11 descendants cleared2023: 9 descendants cleared2021: 11 descendants cleared2026: 19 descendants cleared2024: 17 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 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 2 other ancestors4 generations back: 7 other ancestors5 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 30 descendants4 generations forward: 50 descendants5 generations forward: 47 descendants6 generations forward: 18 descendants7 generations forward: 3 descendants K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · 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. · 1981−50+5
  1. Root · 6 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 5 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 4 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 3 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 2 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 1 generation backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. This deviceK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. Descendant · cites it directly · 114 of its ownK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. Descendant · 2 generations on · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  10. Descendant · cites it directly · 61 of its ownK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
  11. Descendant · 2 generations on · 60 of its ownK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  12. Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled

Showing 5 of 163 descendants. See all descendants

Descendants cleared per year

2009: 22010: 12011: 22012: 62013: 32014: 72015: 62016: 42017: 22018: 92019: 202020: 152021: 112022: 112023: 92024: 172025: 192026: 19
2009high 20 (2019) · low 1 (2010)2026

Most influential descendants

Showing 5 of 163 · See all
  • K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · cites it directly114descendants
  • K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 2 generations on88descendants
  • K082996Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · cites it directly61descendants
  • K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp · 2009 · 2 generations on60descendants
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−5K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−4K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−3K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−2K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−1K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
0 (this device)K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
+1K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
+2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
+1K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.20094
+2K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M…Biomet Manufacturing Corp2009—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199220
199310
199440
199530
199710
200220
200310
200520
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201010
201120
201260
201330
201470
201560
201640
201720
201890
2019200
2020150
2021110
2022110
202390
2024170
2025190
2026190
FIG. 1 — Lineage of K073102, 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? (5)

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
*K042091Biolox Delta Ceramic Heads
Summary page 1
…t/ceramic/polymer semiconstrained cemented or non-cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K.051411 and K061312; 100 kGy E-Poly TM Acetabular Liners-K070364 and K070399. Device Description: Biolox® delta Ceramic Heads…
Biomet, Inc.20052
*K051411Arcomxl Polyethylene Liners and Biolox Delta Heads
Summary page 1
…olymer semiconstrained cemented or non-cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K.051411 and K061312; 100 kGy E-Poly TM Acetabular Liners-K070364 and K070399. Device Description: Biolox® delta Ceramic Heads are design…
Biomet, Inc.20051
*K06131236MM Biolox Delta Ceramic Heads
Summary page 1
…constrained cemented or non-cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K.051411 and K061312; 100 kGy E-Poly TM Acetabular Liners-K070364 and K070399. Device Description: Biolox® delta Ceramic Heads are designed to be the…
Biomet, Inc.2006—
*K070364100KGY E-Poly Maxrom Acetabular Liners
Summary page 1
…is Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K.051411 and K061312; 100 kGy E-Poly TM Acetabular Liners-K070364 and K070399. Device Description: Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replace…
Biomet, Inc.2007—
*K070399100KGY E-Poly Acetabular Liners-Additional Profiles
Summary page 1
…arketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K.051411 and K061312; 100 kGy E-Poly TM Acetabular Liners-K070364 and K070399. Device Description: Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The hi…
Biomet Manufacturing, Inc.2007—

Also cleared against K042091: 6 other devices →

What descends from it? (163)

See all 163

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

NumberDeviceApplicantDecidedDescendants
K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114
K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.200961
K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128

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 2 companies; a new generation was cleared every 1.5 years on median.
  • 6 of the 25 ancestors have a recall of any class.
  • Of its descendants, K100048 (Biomet Manufacturing Corp, 2010) has gone furthest, with 114 descendants of its own.
  • 6 other devices also cite its predicate K042091.

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. 2007, this device’s year, is highlighted.

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 by other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications Biolox® delta Ceramic Heads are indicated for…

Read the full statement (198 words)

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 by other techniques.

5. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications

Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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 by other techniques.

5. Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis.

Indications for use as stated in the FDA summary.

Also cleared against K042091

6 other devices cite the same predicate.

  • K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc. · 20132 recalls
  • K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation · 20111 recall
  • K082996Biolox Delta Option Ceramic HeadsBiomet, Inc. · 20094 recalls
  • K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 20081 recall
  • K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  • K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 20051 recall

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

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/K073102 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly 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/K073102

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