510(k) Report

510(k) · Cleared

Cleared

Zirconia Ceramic Modular Heads (Astro Met)

K943586510(k) TraditionalCleared Oct 17, 199487-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, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Oct 17, 1994 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 346 later devices descend from it.

Decided
Oct 17, 1994
Review
87 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

346 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2006: 1 descendant cleared2009: 5 descendants cleared2011: 12 descendants cleared2007: 2 descendants cleared2013: 20 descendants cleared2008: 2 descendants 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 cleared1990200020102020
  1. This deviceK943586 Zirconia Ceramic Modular Heads (Astro Met)Biomet, Inc. · 1994
  2. Descendant · cites it directly · 345 of its ownK042091 Biolox Delta Ceramic HeadsBiomet, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  5. Descendant · 3 generations on · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled

Showing 5 of 346 descendants. See all descendants

Descendants cleared per year

2005: 22006: 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 (2006)2026

Most influential descendants

Showing 5 of 346 · See all
  • K042091Biolox Delta Ceramic HeadsBiomet, Inc. · 2005 · cites it directly345descendants
  • K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 2 generations on344descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943586Zirconia Ceramic Modular Heads (Astro Met)Biomet, Inc.1994—
+1K042091Biolox Delta Ceramic HeadsBiomet, Inc.20052
+2K051411Arcomxl 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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
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 K943586, 1994–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (346)

See all 346

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042091Biolox Delta Ceramic HeadsBiomet, Inc.2005345

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?

  • Of its descendants, K042091 (Biomet, Inc., 2005) has gone furthest, with 345 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—

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/K943586 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943586: Zirconia Ceramic Modular Heads (Astro Met).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943586

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026