510(k) · Cleared

Cleared

Ortho Development Ceramic Femoral Heads with Pres-Fit Stems

K053587510(k) TraditionalCleared Mar 17, 200684-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

Ortho Development Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Mar 17, 2006 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Mar 17, 2006
Review: 84 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK053587 Ortho Development Ceramic Femoral Heads with Pres-Fit StemsOrtho Development Corp. · 2006
Descendant · cites it directly · 0 of its ownK111936 Ortho Devlopment Ceramic Femoral HeadOrtho Development · 2011

Most influential descendants

Showing 1 of 1 · See all

K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K053587	Ortho Development Ceramic Femoral Heads with Pres-Fit Stems	Ortho Development Corp.	2006	—
+1	K111936	Ortho Devlopment Ceramic Femoral Head	Ortho Development	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K053587, 2006–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

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
K111936	Ortho Devlopment Ceramic Femoral Head	Ortho Development	2011	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?

Of its descendants, K111936 (Ortho Development, 2011) has gone furthest, with 0 descendants of its own.

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 device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia. 2. Previously failed surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5.…

Read the full statement (104 words)

The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.

2. Previously failed surgery.

3. Proximal femoral neck fractures or dislocation.

4. Idiopathic avascular necrosis of the femoral head.

5. Non-union of proximal femoral neck fractures.

6. Treatment of fractures that are unmanageable using other forms of therapy.

7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K053587 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053587: Ortho Development Ceramic Femoral Heads with Pres-Fit Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053587

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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