510(k) Report

510(k) · Cleared

Recalled · 2009

Biolox Delta Ceramic Heads

K042091510(k) TraditionalCleared Mar 25, 2005234-day reviewClass II21 CFR 888.3353Recalls 2

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 Mar 25, 2005 as substantially equivalent to K943586 (Biomet, Inc., 1994) and 3 other predicates after a 234-day review. Its family tree reaches back 2 generations to 2002. 345 later devices descend from it. It has been recalled 2 times.

Decided
Mar 25, 2005
Review
234 days
Class
Class II
Product code
LZO
Recalls
2
Predicates
4

Its longest line of descent runs back 2 generations to K011533 (2002). 5 ancestors in all, the oldest K905687 (1991). 345 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 2 other ancestors1991: 1 other ancestor2006: 1 descendant cleared2009: 5 descendants cleared2011: 12 descendants cleared2007: 2 descendants cleared2013: 20 descendants cleared2008: 2 descendants cleared2005: 1 descendant cleared2012: 13 descendants cleared2010: 4 descendants cleared2020: 25 descendants cleared2025: 30 descendants cleared2014: 15 descendants cleared2022: 22 descendants cleared2015: 16 descendants cleared2019: 31 descendants cleared2016: 15 descendants cleared2017: 15 descendants cleared2018: 20 descendants cleared2021: 19 descendants cleared2023: 21 descendants cleared2026: 27 descendants cleared2024: 29 descendants clearedK011533 · Depuy Femoral Heads · DePuy Orthopaedics, Inc. · 2002K031803 · Depuy Ceramic Femoral Heads · DePuy Orthopaedics, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 15 descendants3 generations forward: 49 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 K031803 · Depuy Ceramic Femoral Heads · DePuy Orthopaedics, Inc. · 2003K011533 · Depuy Femoral Heads · DePuy Orthopaedics, Inc. · 20020+5+10
  1. Root · 2 generations backK011533 Depuy Femoral HeadsDePuy Orthopaedics, Inc. · 2002
  2. 1 generation backK031803 Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003
  3. This deviceK042091 Biolox Delta Ceramic HeadsBiomet, Inc. · 2005
  4. Descendant · cites it directly · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  5. Descendant · cites it directly · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  6. Descendant · 2 generations on · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  7. Descendant · cites it directly · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  8. Descendant · cites it directly · 163 of its ownK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007

Showing 5 of 345 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 22008: 22009: 52010: 42011: 122012: 132013: 202014: 152015: 162016: 152017: 152018: 202019: 312020: 252021: 192022: 222023: 212024: 292025: 302026: 27
2005high 31 (2019) · low 1 (2005)2026

Most influential descendants

Showing 5 of 345 · See all
  • K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · cites it directly344descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K011533Depuy Femoral HeadsDePuy Orthopaedics, Inc.2002—
−1K031803Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2003—
0 (this device)K042091Biolox Delta Ceramic HeadsBiomet, Inc.2005—
+1K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
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 K042091, 2002–2026Source: 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K943586Zirconia Ceramic Modular Heads (Astro Met)
Summary page 1
…d or nonporous uncemented prosthesis. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Zirconia Ceramic Modular Heads cleared through 510(k) K943586, K925345 and K905687 and DePuy Ceramic Femoral Heads cleared through K031803. Device Description: Biolox® delta Ceramic Heads ar…
Biomet, Inc.1994—
*K925345Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM)
Summary page 1
…orous uncemented prosthesis. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Zirconia Ceramic Modular Heads cleared through 510(k) K943586, K925345 and K905687 and DePuy Ceramic Femoral Heads cleared through K031803. Device Description: Biolox® delta Ceramic Heads are designe…
Biomet, Inc.1994—
*K905687Zirconia Ceramic Modular Heads
Summary page 1
…nted prosthesis. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Zirconia Ceramic Modular Heads cleared through 510(k) K943586, K925345 and K905687 and DePuy Ceramic Femoral Heads cleared through K031803. Device Description: Biolox® delta Ceramic Heads are designed to be the…
Biomet, Inc.1991—
*K031803Depuy Ceramic Femoral Heads
Summary page 1
…tantial Equivalence Is Claimed: Biomet Zirconia Ceramic Modular Heads cleared through 510(k) K943586, K925345 and K905687 and DePuy Ceramic Femoral Heads cleared through K031803. Device Description: Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The hi…
DePuy Orthopaedics, Inc.2003—

What descends from it? (345)

See all 345

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
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
K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.20139
K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation20118

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 16, 2009Not classifiedZ-1614-2009Process controlThe firm has received reports of fractured heads, requiring revision surgery.
Mar 16, 2009Not classifiedZ-1613-2009Process controlThe firm has received reports of fractured heads, requiring revision surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K051411 (Biomet, Inc., 2005) has gone furthest, with 344 descendants of its own.

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?

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…

Read the full statement (148 words)

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.

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/K042091 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042091: Biolox Delta Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042091

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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