510(k) · Cleared

Cleared

Alumina Head

K042035510(k) TraditionalCleared Nov 17, 2004111-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

Fournitures Hospitalieres Industrie · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 17, 2004 as substantially equivalent to K012918 (Apex Surgical, LLC, 2001) and 3 other predicates after a 111-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.

Decided: Nov 17, 2004
Review: 111 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K933275 (1994). 26 ancestors in all, the oldest K823727 (1983). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK933275 P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
5 generations backK962248 P.F.C. Ceramic Hip HeadJohnson & Johnson Professionals, Inc. · 1996
4 generations backK973307 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1997
3 generations backK980081 S-Rom Zirconia Ceramic Femoral Hip HeadJohnson & Johnson Professionals, Inc. · 1998
2 generations backK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
1 generation backK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
This deviceK042035 Alumina HeadFournitures Hospitalieres Industrie · 2004
Descendant · cites it directly · 0 of its ownK050556 Alumina HeadFournitures Hospitalieres Industrie · 2005

Most influential descendants

Showing 1 of 1 · See all

K050556Alumina HeadFournitures Hospitalieres Industrie · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K933275	P.F.C. Ceramic Hip Head	Johnson & Johnson Orthopaedics, Inc.	1994	—
−5	K962248	P.F.C. Ceramic Hip Head	Johnson & Johnson Professionals, Inc.	1996	—
−4	K973307	S-Rom Zirconia Ceramic Femoral Hip Head	Johnson & Johnson Professionals, Inc.	1997	—
−3	K980081	S-Rom Zirconia Ceramic Femoral Hip Head	Johnson & Johnson Professionals, Inc.	1998	—
−2	K990261	Plus Ceramic Head Prostheses (Alumina and Zirkonia)	Plus Orthopedics	1999	—
−1	K012918	Apex Modular Alumina Femoral Head	Apex Surgical, LLC	2001	—
0 (this device)	K042035	Alumina Head	Fournitures Hospitalieres Industrie	2004	—
+1	K050556	Alumina Head	Fournitures Hospitalieres Industrie	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	2	0
1986	3	0
1987	2	0
1988	1	0
1990	1	0
1991	1	0
1992	1	0
1993	2	0
1994	2	0
1995	1	0
1997	2	0
1998	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K042035, 1994–2005Source: 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? (4)

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
*	K012918	Apex Modular Alumina Femoral Head	Apex Surgical, LLC	2001	—
*	K981847	Biolox Alumina Ceramic Femoral Head Summary page 2 …ina Femoral Head (KO 1291 8). Apex Surgical & Nephew Biolox Alumina C'eramic Femnoral Head (K981847 & K991 162). Smith intrapiani ceramic Head Prosthesis (K990261 ). Plus orthopedics COMPARISON OF TECHNOLOGICAL CHARACTERIS…	Smith & Nephew, Inc.	1998	—
*	K991162	Biolox Alumina Ceramic Femoral Head Summary page 2 …l Head (KO 1291 8). Apex Surgical & Nephew Biolox Alumina C'eramic Femnoral Head (K981847 & K991 162). Smith intrapiani ceramic Head Prosthesis (K990261 ). Plus orthopedics COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:…	Smith & Nephew, Inc.	2000	—
*	K990261	Plus Ceramic Head Prostheses (Alumina and Zirkonia) Summary page 2 …& Nephew Biolox Alumina C'eramic Femnoral Head (K981847 & K991 162). Smith intrapiani ceramic Head Prosthesis (K990261 ). Plus orthopedics COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:…	Plus Orthopedics	1999	—

Also cleared against K012918: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K050556	Alumina Head	Fournitures Hospitalieres Industrie	2005	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?

The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
None of the 26 ancestors has a recall.
Of its descendants, K050556 (Fournitures Hospitalieres Industrie, 2005) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K012918.

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?

Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head.

The alumina head can only be used with polyethylene inserts.

This prothesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused hip, diastrophic variant, slipped capital epiphysis, non-union.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042035 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042035: Alumina Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042035

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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