510(k) · Cleared

Cleared

Zirconia Ceramic Femoral Head (12/14 Taper)

K971752510(k) TraditionalCleared Jul 30, 199779-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

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

Cleared on Jul 30, 1997 as substantially equivalent to K944601 (Zimmer, Inc., 1995) and 4 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1990.

Decided: Jul 30, 1997
Review: 79 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K901480 (1990). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK901480 F-20 Total Hip ProsthesisMed-Tek Corp. · 1990
This deviceK971752 Zirconia Ceramic Femoral Head (12/14 Taper)Zimmer, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901480	F-20 Total Hip Prosthesis	Med-Tek Corp.	1990	—
0 (this device)	K971752	Zirconia Ceramic Femoral Head (12/14 Taper)	Zimmer, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1995	1	0
1996	2	0

FIG. 1 — Lineage of K971752, 1990–1997Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K944601	Zimmer Zirconia Ceramic Femoral Head Summary page 1 …joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, 21 CFR 888.3353 ¢ Predicate Devices: . Zimmer® Zirconia Ceramic Femoral Head, K944601 and K955877, cleared January 12, 1995, and October 8, 1996, respectively. . Astel Cobalt-Chrome Femoral Heads, manufactured by Z…	Zimmer, Inc.	1995	—
*	K955877	Zimmer Zirconia Ceramic Femoral Head Summary page 1 …/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, 21 CFR 888.3353 ¢ Predicate Devices: . Zimmer® Zirconia Ceramic Femoral Head, K944601 and K955877, cleared January 12, 1995, and October 8, 1996, respectively. . Astel Cobalt-Chrome Femoral Heads, manufactured by Zimmer, K9014…	Zimmer, Inc.	1996	—
*	K901480	F-20 Total Hip Prosthesis Summary page 1 …nia Ceramic Femoral Head, K944601 and K955877, cleared January 12, 1995, and October 8, 1996, respectively. . Astel Cobalt-Chrome Femoral Heads, manufactured by Zimmer, K901480 and K901594, cleared June 12, 1990, and August 3, 1990, respectively. T %Z% A Bristol-Myers Squibb Company Summa…	Med-Tek Corp.	1990	—
*	K901594	H.N. Total Hip Prosthesis Summary page 1 …Femoral Head, K944601 and K955877, cleared January 12, 1995, and October 8, 1996, respectively. . Astel Cobalt-Chrome Femoral Heads, manufactured by Zimmer, K901480 and K901594, cleared June 12, 1990, and August 3, 1990, respectively. T %Z% A Bristol-Myers Squibb Company Summary of Safety…	Med-Tek Corp.	1990	—
*	K953337	Beta Hip Prosthesis Summary page 2 …ffectiveness Zirconia Ceramic Femoral Head (12/14 Taper) (Continued) . Zimmer® Cobalt-Chrome Femoral Heads, described in the premarket notification for the Beta System, K953337, cleared January 22, 1996. Device Description: The Zirconia Ceramic Femoral Head (12/14 taper) is made from yttria stabilized z…	Zimmer, Inc.	1996	15

Also cleared against K944601: 2 other devices →

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?

1 of the 5 ancestors has a recall of any class.
2 other devices also cite its predicate K944601.

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 Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio…

Read the full statement (98 words)

The Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

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/K971752 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971752: Zirconia Ceramic Femoral Head (12/14 Taper).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971752

Report an extraction error

Are you the manufacturer?

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