510(k) · Cleared

Cleared

Depuy Ceramic Femoral Heads

K031803510(k) SpecialCleared Jul 1, 200320-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

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

Cleared on Jul 1, 2003 as substantially equivalent to K011533 (DePuy Orthopaedics, Inc., 2002) after a 20-day review. Its family tree reaches back 1 generation to 2002. 377 later devices descend from it.

Decided: Jul 1, 2003
Review: 20 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011533 (2002). 377 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK011533 Depuy Femoral HeadsDePuy Orthopaedics, Inc. · 2002
This deviceK031803 Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003
Descendant · cites it directly · 345 of its ownK042091 Biolox Delta Ceramic HeadsBiomet, Inc. · 2005 · Recalled
Descendant · 2 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
Descendant · 2 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
Descendant · cites it directly · 222 of its ownK040644 Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004
Descendant · cites it directly · 219 of its ownK062748 Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2006

Showing 5 of 377 descendants. See all descendants

Descendants cleared per year

2004high 33 (2019) · low 1 (2004)2026

Most influential descendants

Showing 5 of 377 · 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
K040644Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004 · cites it directly222descendants
K062748Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2006 · cites it directly219descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011533	Depuy Femoral Heads	DePuy Orthopaedics, Inc.	2002	—
0 (this device)	K031803	Depuy Ceramic Femoral Heads	DePuy Orthopaedics, Inc.	2003	—
+1	K042091	Biolox Delta Ceramic Heads	Biomet, Inc.	2005	2
+2	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
+2	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
+1	K040644	Modification to Depuy Ceramic Femoral Head	DePuy Orthopaedics, Inc.	2004	—
+1	K062748	Modification: to Depuy Delta Ceramic Femoral Head	DePuy Orthopaedics, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	3	0
2006	4	0
2007	3	0
2008	6	0
2009	6	0
2010	5	0
2011	13	0
2012	17	0
2013	20	0
2014	17	0
2015	17	0
2016	16	0
2017	15	0
2018	21	0
2019	33	0
2020	26	0
2021	21	0
2022	25	0
2023	22	0
2024	29	0
2025	30	0
2026	27	0

FIG. 1 — Lineage of K031803, 2002–2026Source: 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

Get a 510(k) Report

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
*	K011533	Depuy Femoral Heads	DePuy Orthopaedics, Inc.	2002	—

Also cleared against K011533: 3 other devices →

What descends from it? (377)

See all 377

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042091	Biolox Delta Ceramic Heads	Biomet, Inc.	2005	345
K040644	Modification to Depuy Ceramic Femoral Head	DePuy Orthopaedics, Inc.	2004	222
K062748	Modification: to Depuy Delta Ceramic Femoral Head	DePuy Orthopaedics, Inc.	2006	219
K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap, Inc.	2006	90
K041940	Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads	Howmedica Osteonics Corp.	2005	18
K071830	Depuy Delta TS Ceramic Femoral Heads	DePuy Orthopaedics, Inc.	2007	14
K222296	ARTICUL/EZE Ceramic Heads	Depuy Ireland UC	2023	6
K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	5
K150576	TGM Biolox delta Ceramic Heads	Tgm Medical, Inc.	2015	0

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, K042091 (Biomet, Inc., 2005) has gone furthest, with 345 descendants of its own.
3 other devices also cite its predicate K011533.

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 DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled…

Read the full statement (122 words)

The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic artlmtis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic hcture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031803: Depuy Ceramic Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031803

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