510(k) · Cleared

Cleared

Zirconia 22.22MM Ceramic Modular Heads

K991708510(k) AbbreviatedCleared Jul 30, 199972-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 Jul 30, 1999 as substantially equivalent to K964431 (Biomet, Inc., 1997) after a 72-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jul 30, 1999
Review: 72 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964431 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK964431 Zirconia Ceramic Modular Heads (Norton Advanced Ceramics)Biomet, Inc. · 1997
This deviceK991708 Zirconia 22.22MM Ceramic Modular HeadsBiomet, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964431	Zirconia Ceramic Modular Heads (Norton Advanced Ceramics)	Biomet, Inc.	1997	—
0 (this device)	K991708	Zirconia 22.22MM Ceramic Modular Heads	Biomet, Inc.	1999	—

FIG. 1 — Lineage of K991708, 1997–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K964431	Zirconia Ceramic Modular Heads (Norton Advanced Ceramics) Summary page 2 …Ceramics are substantially equivalent to other ceramic heads on the market. A predicate to the 22.22 mm head is the Zirconia 28 mm Ceramic Modular Head also by Norton (K964431). Lt %, Cloan: 2 & %, ‘_/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service *, v Food and Drug Admi…	Biomet, Inc.	1997	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

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

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The indications for use of the Zirconia Ceramic Modular Heads include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, and 4) revision of failed hip arthroplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991708: Zirconia 22.22MM Ceramic Modular Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991708

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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