510(k) · Cleared

Cleared

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

K234025510(k) TraditionalCleared Apr 24, 2024126-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

Howmedica Osteonics Corp., Dba Stryker Orthopaedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 24, 2024 as substantially equivalent to K052718 (Howmedica Osteonics Corp., 2005) after a 126-day review. Its family tree reaches back 1 generation to 2005.

Decided: Apr 24, 2024
Review: 126 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052718 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK052718 V40 Biolox Delta Ceramic Femoral HeadsHowmedica Osteonics Corp. · 2005 · Recalled
This deviceK234025 22.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052718	V40 Biolox Delta Ceramic Femoral Heads	Howmedica Osteonics Corp.	2005	2
0 (this device)	K234025	22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2024	—

FIG. 1 — Lineage of K234025, 2005–2024Source: 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
*	K052718	V40 Biolox Delta Ceramic Femoral Heads Summary page 5 …Product Codes: LZO Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed: • V40TM Biolox® delta Ceramic Femoral Heads – K052718 Reason for 510(k) Submission: The purpose of this submission is to introduce a line extension to the existing Biolox® delta Cera…	Howmedica Osteonics Corp.	2005	2

Also cleared against K052718: 5 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?

Its one ancestor has a recall.
5 other devices also cite its predicate K052718.

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. 2024, this device’s year, is highlighted.

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?

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late-stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

4. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

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/K234025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K234025: 22.2mm BIOLOX® delta Ceramic V40™ 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/K234025

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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