510(k) · Cleared

Cleared

P.F.C. Ceramic Hip Head

K962248510(k) TraditionalCleared Aug 29, 199679-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

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

Cleared on Aug 29, 1996 as substantially equivalent to K933275 (Johnson & Johnson Orthopaedics, Inc., 1994) after a 79-day review. Its family tree reaches back 1 generation to 1994. 12 later devices descend from it.

Decided: Aug 29, 1996
Review: 79 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933275 (1994). 12 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
This deviceK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
Descendant · cites it directly · 11 of its ownK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
Descendant · 2 generations on · 10 of its ownK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
Descendant · 3 generations on · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
Descendant · 4 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
Descendant · 5 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1997high 1 (1997) · low 0 (2000)2026

Most influential descendants

Showing 5 of 12 · See all

K973307S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997 · cites it directly11descendants
K980081S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998 · 2 generations on10descendants
K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · 3 generations on9descendants
K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 4 generations on7descendants
K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933275	P.F.C. Ceramic Hip Head	Johnson & Johnson Orthopaedics, Inc.	1994	—
0 (this device)	K962248	P.F.C. Ceramic Hip Head	Johnson & Johnson Professionals, Inc.	1996	—
+1	K973307	S-Rom Zirconia Ceramic Femoral Hip Head	Johnson & Johnson Professionals, Inc.	1997	—
+2	K980081	S-Rom Zirconia Ceramic Femoral Hip Head	Johnson & Johnson Professionals, Inc.	1998	—
+3	K990261	Plus Ceramic Head Prostheses (Alumina and Zirkonia)	Plus Orthopedics	1999	—
+4	K012918	Apex Modular Alumina Femoral Head	Apex Surgical, LLC	2001	—
+5	K101451	Apex Module Hip System Biolox Delta Femoral Head	Omni Life Science, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2001	1	0
2004	1	0
2005	1	0
2010	1	0
2013	1	0
2017	1	0
2021	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K962248, 1994–2026Source: 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
*	K933275	P.F.C. Ceramic Hip Head Summary page 1 …d indicated for use with the P.F.C. Cemented Hip Stem, Ultima Cemented Hip Stem and Ultima Cemented Long Stem. The P.F.C. Ceramic Hip Head has been cleared under 510(k) K933275. Device Classification Ceramic Hip Heads have been placed into Class II by 21 CFR 888.3353. Statement of Substantial Equivalen…	Johnson & Johnson Orthopaedics, Inc.	1994	—

Also cleared against K933275: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K973307	S-Rom Zirconia Ceramic Femoral Hip Head	Johnson & Johnson Professionals, Inc.	1997	11

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.
Of its descendants, K973307 (Johnson & Johnson Professionals, Inc., 1997) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K933275.

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 Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA).

The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.’s femoral stems with a 12/14 Morse-type taper.

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/K962248 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962248: P.F.C. Ceramic Hip Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962248

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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